BD PosiFlush 306546Recalls & reported problems
Becton, Dickinson And Company · SYRINGE 10ML REG PR SALINE 10ML FILL · Class 2
All models of BD PosiFlush (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD PosiFlush is a 10 mL saline syringe used to flush intravenous lines. Of the 603 reports naming it, many describe flushes that fail to deliver, leak or stick, along with foreign matter such as mold, black specks or cloudiness in the saline. The reports include 11 injuries and 1 death. No recalls name this device.
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
- 608
- Deaths reported
- 1
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 608 adverse event reports that list this exact device (DI 00382903065462), received between Jan 16, 2018 and Sep 28, 2026 — classified as 1 death, 11 injuries, 596 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (207 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Deliver207
- Leak/Splash187
- Physical Resistance/Sticking75
- Device Contamination with Chemical or Other Material52
- Device Markings/Labelling Problem27
- Defective Component24
- Material Separation18
- Contamination15
Patient problems
- No Clinical Signs, Symptoms or Conditions432
- No Known Impact Or Consequence To Patient96
- No Consequences Or Impact To Patient44
- Insufficient Information14
- No Information10
- No Patient Involvement8
- Hypersensitivity/Allergic reaction3
- Pain3
Recent adverse event reports
The 25 most recent of 608 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Infusion or Flow Problem
It was reported, Syringe 10 ML saline, pump alarm, line was occluded.The following was provided by the initial reporter: Pt received her aloxi dose on the infusion pump without alarms. A normal saline flush was placed on the microbore tubing and flush was programed on the syringe pump. Syring pump then alarmed that the line was occluded. RN unable to restart the syringe pump without having the occluded alarm. RN was able to hand push the saline flush on the microbore tubing without resistance.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913812 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790363 ↗MalfunctionSep 15, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776480 ↗MalfunctionSep 13, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747931 ↗MalfunctionSep 13, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747930 ↗MalfunctionAug 26, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50454714 ↗MalfunctionAug 3, 2026Entrapment of Device; Difficult to Remove; Physical Resistance/Sticking
After placing PIV "[peripheral IV]" and flushing lumen to check patency, saline flush was removed from the connection point to connect the patient to the fluid line. Upon removing flush, there was a very slight amount of resistance. When the flush came off, the inside part of the flush connection was stuck inside of the connection site on the IV. This piece was lodged into the IV and unable to be removed. PIV had to be removed from patient, and a new PIV was placed for treatment.
Patient problems: Insufficient Information
MAUDE report 50115656 ↗MalfunctionJun 26, 2026Contamination
IT WAS REPORTED, SYRINGE 10 ML REG PR SALINE, FOREIGN MATTER-MOLD. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE SALINE FLUSHES WAS FOUND WITH MOLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25637160 ↗MalfunctionJun 15, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED, SYRINGE 10ML REG PR SALINE 10ML FILL, FOREIGN MATTER. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: HAS LARGE BLACK SPECK IN SYRINGE. TOTAL NUMBER OF OCCURRENCES: 2. WAS THE PATIENT IMPACTED? DID NOT USE. WAS ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO A HEALTHCARE PROFESSIONAL? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25502800 ↗MalfunctionMay 1, 2026Crack; Leak/Splash
IT IS REPORTED, POSIFLUSH, SMALL CRACK DOWN THE SIDE OF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055972 ↗MalfunctionApr 20, 2026Material Discolored
IT IS REPORTED, SOLUTION INSIDE IS VERY CLOUDY AND DOESN¿T LOOK LIKE NS EITHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24925899 ↗MalfunctionApr 6, 2026Contamination
IT WAS REPORTED, BLACK DOTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791909 ↗MalfunctionMar 20, 2026Material Discolored
IT WAS REPORTED THAT THE BD SYRINGE 10ML REG PR SALINE 10ML FILL HAD DISCOLORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 306546 BATCH # 5295643, 5288002. (B)(4) RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CUSTOMER STATES THEY FOUND SOME 10ML BD FLUSH SYRINGES THAT APPEAR CLOUDY. UNKNOWN TOTAL NUMBER OF QUANTITY. MORE THAN 1 FOR SURE. ADDITIONAL INFORMATION PROVIDED: PLEASE CLARIFY WHAT IS CLOUDY. THE SALINE SOLUTION? YES? THE SYRINGE/MOLDED PARTS? YES?
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24653533 ↗MalfunctionMar 20, 2026Material Discolored
IT WAS REPORTED THAT THE BD SYRINGE 10ML REG PR SALINE 10ML FILL HAD DISCOLORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 306546 BATCH # 5295643, 5288002 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CUSTOMER STATES THEY FOUND SOME 10ML BD FLUSH SYRINGES THAT APPEAR CLOUDY. UNKNOWN TOTAL NUMBER OF QUANTITY. MORE THAN 1 FOR SURE. ADDITIONAL INFORMATION PROVIDED: PLEASE CLARIFY WHAT IS CLOUDY. - THE SALINE SOLUTION? YES? - THE SYRINGE/MOLDED PARTS? YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24652671 ↗MalfunctionFeb 23, 2026Air/Gas in Device
WENT TO FLUSH IV WITH PREFILLED 10ML POSIFLUSH AND DREW BLOOD RETURN INTO SYRINGE, REALIZED THE SYRINGE WAS FILLED WITH AIR, NO SALINE. NO AIR WAS INJECTED INTO THE IV, NO IMPACT TO PT. SYRINGE WAS DISCONNECTED FROM IV SITE AND PLACED ASIDE. NEW FLUSH WAS CONNECTED AND USED WITHOUT INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24424636 ↗MalfunctionFeb 20, 2026Contamination
IT WAS REPORTED BY CUSTOMER THAT THE NURSE NOTICED THE LEUR LOCK AREA OF THE SYRINGE WAS CONTAMINATED WITH A DARK RED SUBSTANCE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400623 ↗MalfunctionJan 26, 2026Contamination
IT IS REPORTED FOREIGN MATTER INSIDE SYRINGE. VERBATIM: AS YOU CAN SEE IN THE PHOTOS, THERE APPEARS TO BE AN UNIDENTIFIED SUBSTANCE INSIDE THE SYRINGE. FORTUNATELY, THE NURSE CAUGHT IT BEFORE USE. WE CHECKED BOTH FLOOR STOCK AND INVENTORY BUT DID NOT FIND ANY ADDITIONAL SYRINGES FROM THIS LOT, OR ANY OTHER LOT, WITH SIMILAR ISSUES. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24176704 ↗MalfunctionJan 12, 2026Component Missing
IT WAS REPORTED THAT THE BD SYRINGE 10ML REG PR SALINE 10ML FILL TIP CAP WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 306546 BATCH # 5233237. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. INJURIES OR ADVERSE EVENT: NO. ITEM: 306546. QUANTITY AFFECTED: 1EA. SERIAL/LOT NUMBER: (B)(6). PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. ARE SAMPLES POTENTIALLY CONTAMINATED OR BIOHAZARD? NO. REPORTED ISSUE: WE HAVE BEEN RECEIVING MULTIPLE FLUSHES WITHOUT THE WHITE CAP ON THEM CUSTOMER DISPOSITION REQUEST: REPLACEMENT. ADDITIONAL INFORMATION: DATE OF EVENT: 12-19-2025. TOTAL OCCURRENCES: ONLY RECEIVED 1 EACH NURSE STATED THEY HAD FOUND THREE TO FOUR WITHOUT CAPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24047011 ↗MalfunctionJan 7, 2026Contamination
IT WAS REPORTED THAT BD SYRINGE 10ML REG PR SALINE 10ML FILL CONTAINED FOREIGN MATTER. 1 SYRINGE THAT HAS A BLACK SUBSTANCE ON THE TIP OF THE SYRINGE AND IT IS ALSO ON THE INSIDE THREADS OF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23994339 ↗MalfunctionDec 5, 2025Contamination; Contamination
WE HAD SOME CONTAMINATION OF SYRINGES WE FOUND CUSTOMER RESPONSE: ON (B)(6) 2025. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? 11/13/2025. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM, INJURY, NS FLUSH THAT LOOKED ORANGE AND WITH PARTICLES IN IT. THE SYRINGE IS COMPLETELY SEALED IN ITS PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23733018 ↗MalfunctionNov 14, 2025Fluid/Blood Leak
FROM STAFF: WHEN THE RN CARING FOR INFANT WAS CHECKING THE LINES, IT WAS NOTED THE MEDICATION TUBING WAS WET. WHEN GOING TO HANG AN IV MEDICATION THE RN HUNG NEW TUBING. UPON SHIFT CHANGE AND NURSE HAND OFF THE NEW TUBING WAS ALSO NOTED TO BE WET. UPON FURTHER INVESTIGATION THE TUBING WAS NOTED TO BE LEAKING AROUND THE FILTER OR POSSIBLY THE FILTER BEING CRACKED, AND PACKAGING WAS SAVED TO FOLLOW LOT NUMBER (#14329474). THE PREVIOUS TUBING WAS ALSO RETRIEVED AND INVESTIGATED TO ALSO BE LEAKING AROUND THE FILTER. ALL TUBING WITH SIMILAR LOT NUMBERS SET ASIDE ON THE UNIT UNTIL FURTHER EVALUATION OF ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23554600 ↗MalfunctionNov 13, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23550836 ↗MalfunctionNov 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE BD SYRINGE 10ML REG PR SALINE 10ML FILL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 306546 BATCH # 5111174 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ACCOUNT NAME: GPOID: (B)(4). COID: (B)(4). CONTRACT NUMBER: (B)(4). MANUFACTURER: BD MEDICAL. PLEASE REVIEW AND PROVIDE A RESPONSE TO THE PRODUCT QUALITY ISSUE REPORTED. PLEASE CONTACT THE FACILITY DIRECTLY FOR DETAILS, SAMPLE COLLECTION AND RESOLUTION. WHEN THE INVESTIGATION HAS COMPLETED, PLEASE PROVIDE HEALTH TRUST WITH A COPY OF THE FINAL LETTER IN ORDER TO CLOSE OUT THE TICKET IN THE HEALTH TRUST DATABASE. I WILL FOLLOW UP WITH YOU FOR A STATUS UPDATE IN A COUPLE OF WEEKS. FACILITY CONTACT: DEPARTMENT: MATERIALS MANAGEMENT PHONE NUMBER: EMAIL: JUSTICE PRODUCT CATALOG NUMBER:306546 PRODUCT DESCRIPTION: SYRINGE PREFILLED FLUSH 10ML SALINE 10ML POSIFLUSH LUER LOCK STERILE DISPOSABLE LATEX FREE ORIGIN OF THE ISSUE: NURSING DETAIL: ON FRIDAY EVENING, (B)(6) 2025, NURSING STAFF OBSERVED VISIBLE PARTICULATES AFTER EXPRESSING A BD POSIFLUSH 0.9 SODIUM CHLORIDE INJECTION, USP 10 ML, SYRINGE FROM LOT 5111174 INTO A SINK. NO PATIENT WAS INJECTE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23463365 ↗MalfunctionNov 3, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
(B)(4) IS A DUPLICATE COMPLAINT AND WILL BE CANCELLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23459867 ↗MalfunctionOct 22, 2025Fluid/Blood Leak
FROM STAFF: BEDSIDE REPORT AND IVF [INTRAVENOUS FLUID] RATES BEING VERIFIED. LEAKING FLUID NOTED FROM MEDICATION LINE FILTER THAT IS ATTACHED TO PICC [PERIPHERALLY INSERTED CENTRAL CATHETER]. LIQUID NOTED AT SITE OF FILTER, SOAKED LABEL ON THE LINE AND DROPLETS NOTED ALONG MED LINE. NOTHING INFUSING VIA MED LINE AT THIS TIME. MEDICATION LINE HAD BEEN CHANGED THE PREVIOUS SHIFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23356630 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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