BD Ultra-Fine 328438Recalls & reported problems
Becton, Dickinson and Company Inc · BD Insulin Syringes with BD Ultra-Fine Needle, U-100, 8mm, 31G, 0.3mL · Class 2
All models of BD Ultra-Fine (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Ultra-Fine insulin syringe is a small syringe with a very thin needle used to inject insulin. Many of the 315 reports describe leaks or splashing, failed dose delivery, and labeling problems, and a few mention needle sticks. There were 4 injury reports and no deaths, and no recalls name this device. Reports fell to 1 in the latest 12 months from 5 in the 12 months before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 316
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 316 adverse event reports that list this exact device (DI 00382908438032), received between Oct 23, 2017 and Sep 9, 2026 — classified as 4 injuries, 312 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (144 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash144
- Failure to Deliver35
- Device Contamination with Chemical or Other Material33
- Device Markings/Labelling Problem32
- Break26
- Defective Device9
- Material Separation9
- Volume Accuracy Problem7
Patient problems
- No Clinical Signs, Symptoms or Conditions121
- No Known Impact Or Consequence To Patient104
- No Consequences Or Impact To Patient79
- No Patient Involvement18
- Needle Stick/Puncture5
- No Information3
- Foreign Body In Patient1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 316 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691215 ↗MalfunctionJan 5, 2026Off-Label Use
ACCOUNT - MCKESSON MEDICAL-SURGICAL SKU# 328438 SYRINGE/NDL, INSULIN 3/10CC 31 LOT#S 4226017 & 4198011. COMPLAINT - ONE OF OUR CUSTOMERS IS HAVING AN ONGOING ISSUE WITH ONE OF YOUR ITEMS. ITEM 328438/SYRINGE/NDL, INSULIN 3/10CC 31. I HAVE BEEN PROVIDED WITH TWO DIFFERENT LOT NUMBERS OF 4226017, 4198011. CUSTOMER IS REPORTING THAT IT IS NOT EVERY NEEDLE, MAY BE 1-2 PER PACK. THEY ARE USING A MAGNIFYING GLASS AND INSPECTING THEM ONE BY ONE TO ENSUE BOTOX IS NOT WASTED ON DEFECTIVE NEEDLES THAT WILL NOT PUNCTURE THROUGH SKIN AND CAUSE PATIENTS EXCESSIVE PAIN. THIS ITEM HAS BEEN PURCHASED BY THIS CUSTOMER WHEN THE PRODUCT WAS OWNED BY BD AND HAS NOT HAD ANY ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23956477 ↗MalfunctionApr 24, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
PHARMACIST CALLED IN TO GET ASSISTANCE WITH DETERMINING THE EXPIRATION DATE BASED ON THE LOT NUMBER. STATED, SHE DID NOT SEE AN EXPIRATION DATE ON THE BOX. STATED, THE BOX WAS OPENED AND SHE THINKS SOME WERE GIVEN OUT. DID NOT LOOK INSIDE TO COUNT THE PACKAGES. LOT: 5195531, CATALOG: 328438, SAMPLES: NO-WILL BE DISCARDING THEM. SEE RELATED CASES, (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21901573 ↗MalfunctionApr 17, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
HOW OFTEN HAS THE ISSUE OCCURRED? ONCE WHEN DID THE INCIDENT OCCUR? UNKNOWN DESCRIPTION HCP EMAIL COMMENTS. NOT KNOWING DATE OF EXP OF PRODUCTS. DATES MISSING FROM BOX. HCP CHECKING ON DATES. EMAIL DOES NOT STATE IF ITEMS WERE USED 1. BD INSULIN SYRINGES WITH THE BD ULTRA-FINE NEEDLE, CAPACITY: ½ ML CC, LENGTH: 12.77 MM, GAUGE: 30G, LOT #: 5159577. 2. BD INSULIN SYRINGES WITH THE BD ULTRA-FINE NEEDLE, CAPACITY: 3/10 ML CC, LENGTH: 8MM, GAUGE: 31G, LOT #: 5195531. 3. BD INSULIN SYRINGES WITH THE BD ULTRA- FINE NEEDLE, CAPACITY: 1 ML CC, LENGTH: 8MM, GAUGE: 31G, LOT #: 4349670. FROM: CUSTOMER CARE SENT: MONDAY, (B)(6) 2025 3:40 PM TO: (B)(6) SUBJECT: FWD: YOU HAVE A REPLY - REQ-(B)(4) - FW: MEDICAL INQUIRY RESPONSE FOR: (B)(4). HELLO TEAM, PLEASE LOOK INTO THE FOLLOWING QUERY AND DO THE NEEDFUL. THANKS, AND REGARDS, EMBECTA CUSTOMER SUPPORT ON MON, (B)(6) 4:06 PM, MEDICAL <(B)(6)> WROTE: CUSTOMER CARE TEAM, THIS CAME THROUGH TO THE MEDICAL INFORMATION MAILBOX TODAY, WOULD EITHER OF YOU BE ABLE TO ADDRESS THEIR CONCERN AROUND EXPIRATION. SENT: MONDAY, (B)(6) 2025, 3:25 PM TO: MEDICAL INFORMATION <(B)(6)> SUBJECT: FW: MEDICAL INQUIRY RESPONSE FOR: (B)(4). HI, PLEASE SEE EMAIL BELOW. I
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21858442 ↗MalfunctionMar 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
CONSUMER REPORTED, JUST AS SHE WAS ABOUT TO DRAW UP HER INSULIN, SHE NOTICED A "BLACK RING" AROUND THE NEEDLE TIP. STATED, SHE TRIED TO REMOVE TO FOREIGN MATTER/"BLACK RING" BUT IT WAS STUCK ON THERE. 1 SYRINGE AFFECTED. LOT: 4164062. CATALOG: 328438. DATE OF EVENT: 02-21-2025. SAMPLES: YES (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21652978 ↗MalfunctionJan 5, 2025Off-Label Use; Device Contamination with Chemical or Other Material; Off-Label Use; Device Contamination with Chemical or Other Material
MATERIAL # 328438 MATERIAL DESCRIPTION - SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 MATERIAL LOT# - 3268213 & 4121016 COMPLAINT DESCRIPTION ¿ JUST WONDERING IF ANYONE ELSE HAS COMPLAINED ABOUT NOTCHES BEING IN THE MIDDLE OF THE BD INSULIN SYRINGES. WE NOW HAVE HAD MULTIPLE PACKS WITH NOTCHES IN THE MIDDLE OF THE SYRINGES. WE USE THESE SYRINGES ON OUR BOTOX PATIENTS AND SOME OF THEM ARE COMPLAINING IT HURTS MORE WHEN INJECTING. I ATTACHED A PHOTO OF ONE OF THE NEEDLES OUT OF A PACK. IT IS A LITTLE BLURRY, BUT YOU CAN SEE IN THE MIDDLE OF THE SYRINGE LITTLE WHITE MARKS (THOSE ARE THE NOTCH(ES). NOT ALL THE SYRINGES HAVE THEM BUT A GOOD AMOUNT OF THE DO. CAN YOU PLEASE LET ME KNOW HOW I CAN GET THESE REPLACED AS THE PROVIDERS ARE AVOIDING USE THOSE. SOME HAVE ALREADY BEEN DISCARDED OR USED ON PATIENTS. THE CUSTOMER SAID THAT SOME FROM TWO DIFFERENT LOT NUMBERS HAVE BEEN EFFECTED. PLEASE SEND 1 BX AS REPLACEMENT. NOTES - THE CUSTOMER HAS NOT PROVIDED ANY PHOTOS FOR REFERENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21076514 ↗MalfunctionNov 11, 2024Leak/Splash; Leak/Splash
CONSUMER REPORTED THAT THERE IS LIQUID COMING OUT OF THE NEEDLE WHEN SHE DEPRESSES THE PLUNGER ROD. LOT #: 4037015, 4121016 CATALOG #: 328438 DATE OF EVENT: UNKNOWN SAMPLES: AVAILABLE - SENDING MAIL KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20659072 ↗MalfunctionOct 18, 2024Volume Accuracy Problem; Volume Accuracy Problem
DATE: 09/26/2024. COMPLAINT NUMBER: (B)(4). ITEM NUMBER: B-D328438Z. ITEM DESCRIPTION: SYRINGE, INSULIN, 0.3ML, 31GX 5/16." INCIDENT DESCRIPTION: NOT LEGIBLE LINES. HELLO, WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER AND CC XXXXXX.COM AND XXXXXXX.COM ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: NO. ITEM: 328438. QUANTITY AFFECTED: 30 BG. SERIAL/LOT NUMBER: (B)(6)/100382908438032. PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: CUSTOMER DISPOSITION REQUEST: CUST: WE ORDERED THESE A FEW WEEKS AGO AND THE PRINT IS MESSED UP ON THEM. OUR DOCTORS CAN'T USE THEM BECAUSE THEY CAN'T ACCURATELY TELL WHICH LINE IS WHICH. WE HAVE NEVER HAD THIS PROBLEM EXCEPT THIS TIME. WE HAVE TOSSED AT LEAST 30 SYRINGES BECAUSE THEY ARE UNLEDGEABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20482291 ↗MalfunctionSep 20, 2024Leak/Splash; Leak/Splash
CONSUMER REPORTED FOUND 2 SYRINGES FROM THIS 10 PACK - WHEN REMOVED THE NEEDLE SHIELD, THE NEEDLE HUB REMOVED WITH IT. DC. LOT#: 9343326A, CATALOG#: 328438, DATE OF EVENT UNKNOWN, SAMPLE STATUS AWAITING SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20268542 ↗MalfunctionJul 8, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
MATERIAL # 328438 MATERIAL DESCRIPTION - SYRINGE 0.3ML 31G 8MM WHOLE UNIT 10BG 500 MATERIAL LOT# - 4037015 COMPLAINT DESCRIPTION ¿ BD INSULIN SYRINGE 31G 8MM WE PURCHASED FROM HENRY SCHEIN. LOT # 4037015 ITEM NDC/HRI # 08290-8438-01.328438 DR LAFRANCE OPENED THE SYRINGE AND WHEN HE WENT TO PUSH THE SYRINGE DOWN TO ZERO IT OUT A LIQUID DOT AS YOU CAN SEE WAS NOTED. WE HAVE 5 SYRINGES SO FAR THAT THIS HAS HAPPENED TO. IS THIS A LUBRICANT IN THE SYRINGE? THIS HAS NEVER HAPPENED BEFORE AND OBVIOUSLY WE ARE CONCERNED ABOUT THE PRODUCT AND HESITANT TO USE THE SYRINGES. NOTE: THE ORIGINAL REQUEST THAT WE RECEIVED IN MAIL IS ATTACHED FOR FURTHER REFERENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19690906 ↗MalfunctionJul 3, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
CONSUMER REPORTED LIQUID AT THE TIP OF NEEDLES. HE SAID HE NOTICED IT WHEN HE DEPRESSED THE PLUNGER ROD. LOT #: 3254919 CATALOG #: 328438 DATE OF EVENT: 06-10-24 SAMPLES: AVAILABLE - SENDING MAIL KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19669343 ↗MalfunctionJul 2, 2024Leak/Splash; Leak/Splash
CONSUMER REPORTED NEEDLE HUB SEPARATED. ALSO REPORTED NEEDLES BENT WHEN SHIELD IS REMOVED. LOT #: 3191925. CATALOG #: 328438. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19656433 ↗MalfunctionJun 27, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
CONSUMER REPORTED SEEING "CLEAR LIQUID" IN THE BARREL OF SYRINGES BEFORE DRAWING UP INSULIN. STATED, WHEN HE FINDS A SYRINGE WITH THE "CLEAR LIQUID", HET SETS IT TO THE SIDE AND WILL NOT USE IT FOR HIS INJECTION. LOT: 3268213 CATALOG: 328438 DATE OF EVENT: UNKNOWN SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629997 ↗MalfunctionJun 13, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
PHARMACY REPORTED FOUND PRODUCT BELIEVE TO BE EXPIRED. BUT NO EXP DATE ON THE BOX FOUND. FROM INFORMATION RECEIVED, LOT # AND ITEM NUMBER PLUS COPY DATE, ITEM IS EXPIRED. DC LOT # 4155996. CATALOG# 328438. DATE OF EVENT 05.22.2024. SAMPLE STATUS DISCARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19533331 ↗MalfunctionApr 3, 2024Failure to Deliver; Failure to Deliver
MATERIAL # : 328438. MATERIAL DESCRIPTION: SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500. COMPLAINT DESCRIPTION: CUSTOMER HAS BEEN HAVING ISSUES WITH THESE SYRINGES FOR QUITE SOME TIME. CUSTOMER TOSSED A LOT OUT, THINKING IT WAS JUST A BAD BATCH BUT NOW KEEPS ON HAPPENING. THE BOLDER WRITING SYRINGES ARE HARDER TO PUSH OUT ONCE FILLED WITH TOXINS. PROVIDER NOTE: DIFFICULT TO PUSH OUT SMALLER AMOUNTS OF MEDICATION EXTREMELY DIFFICULT TO CONTROL PUSH. WRONG DOSAGES DUE TO ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19037703 ↗MalfunctionApr 3, 2024Failure to Deliver; Failure to Deliver
MATERIAL # : 328438. MATERIAL DESCRIPTION: SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500. COMPLAINT DESCRIPTION: CUSTOMER HAS BEEN HAVING ISSUES WITH THESE SYRINGES FOR QUITE SOME TIME. CUSTOMER TOSSED A LOT OUT, THINKING IT WAS JUST A BAD BATCH BUT NOW KEEPS ON HAPPENING. THE BOLDER WRITING SYRINGES ARE HARDER TO PUSH OUT ONCE FILLED WITH TOXINS. PROVIDER NOTE: DIFFICULT TO PUSH OUT SMALLER AMOUNTS OF MEDICATION EXTREMELY DIFFICULT TO CONTROL PUSH. WRONG DOSAGES DUE TO ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19037701 ↗MalfunctionMar 29, 2024Off-Label Use; Device Contamination with Chemical or Other Material; No Pressure; Off-Label Use; Device Contamination with Chemical or Other Material; No Pressure
PRODUCT IS BEING USED FOR BOTOX INJECTIONS/OFF LABEL USE NURSE REPORTED. SEEING CLEAR LIQUID IN THE BARREL OF SYRINGE PRIOR TO INJECTION. DOES NOT USE SYRINGES IF CLEAR LIQUID IS SEEN. LOT: 2332730, 3254919, 3219226 CATALOG: 328438 DATE OF EVENT: UNKNOWN SAMPLES: YES SAMPLES WILL BE COMING IN FROM ALL THREE LOT NUMBERS. NO REPLACEMENT GOING OUT. CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19008652 ↗MalfunctionMar 29, 2024Off-Label Use; Device Contamination with Chemical or Other Material; Off-Label Use; Device Contamination with Chemical or Other Material
PRODUCT IS BEING USED FOR BOTOX INJECTIONS/OFF LABEL USE NURSE REPORTED. SEEING CLEAR LIQUID IN THE BARREL OF SYRINGE PRIOR TO INJECTION. DOES NOT USE SYRINGES IF CLEAR LIQUID IS SEEN. LOT: 2332730, 3254919, 3219226 CATALOG: 328438 DATE OF EVENT: UNKNOWN SAMPLES: YES SAMPLES WILL BE COMING IN FROM ALL THREE LOT NUMBERS. NO REPLACEMENT GOING OUT. CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19008181 ↗MalfunctionMar 29, 2024Off-Label Use; Device Contamination with Chemical or Other Material; Off-Label Use; Device Contamination with Chemical or Other Material
PRODUCT IS BEING USED FOR BOTOX INJECTIONS/OFF LABEL USE NURSE REPORTED. SEEING CLEAR LIQUID IN THE BARREL OF SYRINGE PRIOR TO INJECTION. DOES NOT USE SYRINGES IF CLEAR LIQUID IS SEEN. LOT: 2332730, 3254919, 3219226 CATALOG: 328438 DATE OF EVENT: UNKNOWN SAMPLES: YES SAMPLES WILL BE COMING IN FROM ALL THREE LOT NUMBERS. NO REPLACEMENT GOING OUT. CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19008176 ↗MalfunctionDec 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE LEAKS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT LEAKS DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18400923 ↗MalfunctionDec 14, 2023Break; Break
IT WAS REPORTED WHILE USING THE BD ULTRA-FINE¿ INSULIN SYRINGE THE PLUNGER SEPARATED. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED, WHEN SHE REMOVED THE PLUNGER CAP PRIOR TO INJECTION, THE "FLANGES/THUMB PRESS" BROKE OFF. STATED, SHE COULD NOT USE THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18332728 ↗MalfunctionNov 29, 2023Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT WHILE USING THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE, THE NEEDLE WENT THROUGH SHIELD WHILE RESHIELDING CAUSING A NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE BENT DURING INJECTION. NEEDLE THROUGH SHIELD WHILE RESHIELDING. NEEDLE STICK DUE TO NEEDLE THROUGH THE SHIELD WHILE RESHIELDING.
Patient problems: Needle Stick/Puncture
MAUDE report 18234795 ↗MalfunctionNov 8, 2023Break; Break
IT WAS REPORTED WHILE USING THE BD ULTRA-FINE¿ INSULIN SYRINGE THE PLUNGER SEPARATED. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED, WHEN SHE REMOVED THE PLUNGER CAP PRIOR TO INJECTION, THE "FLANGES/THUMB PRESS" BROKE OFF. STATED, SHE COULD NOT USE THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093559 ↗MalfunctionOct 19, 2023Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WAS CLOGGED DURING THE INSULIN INJECTION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REPORTED ISSUE: NEEDLE BENDS EASILY, SYRINGE PLUG GETS STUCK. HAVE TO POKE SEVERAL TIMES TO GET THRU SKIN... ADD INFO RECEIVED ON 17-OCT-2023. 1ST CUSTOMER RESPONSE ¿ ARE YOU ABLE TO PROVIDE THE INCIDENT DATE? THERE WAS MORE THAN ONE DATE THAT THE INCIDENT OCCURRED. THE INCIDENT OCCURRED MULTIPLE TIMES DURING THE MONTH OF SEPTEMBER. 9/18, 9/22, 9/27, 9/29, 10/2 ¿ WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? YES, PROVIDER WOULD HAVE TO SWITCH SYRINGES DUE TO NEEDLE BENDING AND NOT PENETRATING THE SKIN AND PROVIDER/PATIENT WOULD NEED TO MAKE MULTIPLE ATTEMPTS OF INJECTING AT THE INJECTION SITE. ¿ WHAT TYPE OF PROCEDURE IS BEING PERFORMED? INJECTION ¿ WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? SEMAGLUTIDE"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17966998 ↗MalfunctionOct 19, 2023Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WAS CLOGGED DURING THE INSULIN INJECTION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 5TH OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REPORTED ISSUE: NEEDLE BENDS EASILY, SYRINGE PLUG GETS STUCK. HAVE TO POKE SEVERAL TIMES TO GET THRU SKIN. ADD INFO RECEIVED ON 17-OCT-2023. 1ST CUSTOMER RESPONSE ¿ ARE YOU ABLE TO PROVIDE THE INCIDENT DATE?: THERE WAS MORE THAN ONE DATE THAT THE INCIDENT OCCURRED. THE INCIDENT OCCURRED MULTIPLE TIMES DURING THE MONTH OF (B)(6). ¿ WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT?: YES, PROVIDER WOULD HAVE TO SWITCH SYRINGES DUE TO NEEDLE BENDING AND NOT PENETRATING THE SKIN AND PROVIDER/PATIENT WOULD NEED TO MAKE MULTIPLE ATTEMPTS OF INJECTING AT THE INJECTION SITE. ¿ WHAT TYPE OF PROCEDURE IS BEING PERFORMED?: INJECTION. ¿ WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT?: SEMAGLUTIDE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17966972 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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