BD Plastipak Syringe 300865Recalls & reported problems
Becton, Dickinson And Company · SYRINGE 50ML LL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Plastipak syringe has 500 reports that often describe leaks, oily or silicone residue inside the syringe, and foreign matter found before use. There are no deaths and 5 injuries reported, and patient problems listed include low blood pressure and a foreign body in the patient. No recalls name this device, and reports fell to 84 in the past year from 137 in the year 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
- 515
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 515 adverse event reports that list this exact device (DI 00382903008650), received between Jul 18, 2018 and Sep 28, 2026 — classified as 5 injuries, 510 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (118 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/Splash118
- Device Contamination with Chemical or Other Material117
- Contamination116
- Break39
- Defective Component20
- Defective Device14
- Infusion or Flow Problem14
- Material Deformation11
Patient problems
- No Clinical Signs, Symptoms or Conditions465
- No Known Impact Or Consequence To Patient26
- Insufficient Information21
- Low Blood Pressure/ Hypotension6
- Dizziness1
- Foreign Body In Patient1
- Hypoglycemia1
- Increased Respiratory Rate1
Recent adverse event reports
The 25 most recent of 515 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926173 ↗MalfunctionSep 22, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860949 ↗MalfunctionSep 22, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859147 ↗MalfunctionSep 22, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859146 ↗MalfunctionSep 21, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846928 ↗MalfunctionSep 18, 2026Air/Gas in Device
The following information was provided by the initial reporter:Reference: 300865Lot: 2605094Date of incident: 08 24 2026We are contacting you to inform you of a problem encountered with potentially two of your products: ¿50ML LUER LOCK SYRINGE IN SYRINGE¿It was reported that This morning during my 8:00 a.m. rounds, I discovered that the tubing connected to the infusion rack was full of air bubbles. Upon closer inspection, I noticed that the syringe pump tubing connected to the rack was also filled with air and a small amount of solvent. The syringe had been properly primed, but air had entered the tubing for no apparent reason.However, the syringe fit the tubing properly, with no signs of wear or damage.This had already been observed last week, so we decided to file a report to inform the pharmacy so they can monitor the equipment closely and avoid causing complications for the patient.Here is the equipment potentially involved:50 mL Luer Lock syringe 300865150 cm 3 valve tubing RNC3315A150 cm PE linear extension tube PB3115MClarification via phone:The syringe was half full when the problem was discovered. The solution in the IV bag was Scoburen. The patient was also receiving Mida
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817528 ↗MalfunctionSep 18, 2026Air/Gas in Device
The following information was provided by the initial reporter:Reference: 300865Lot: 2605094Date of incident: (b)(6)2026We are contacting you to inform you of a problem encountered with potentially two of your products: ¿50ML LUER LOCK SYRINGE IN SYRINGE¿It was reported that This morning during my 8:00 a.m. rounds, I discovered that the tubing connected to the infusion rack was full of air bubbles. Upon closer inspection, I noticed that the syringe pump tubing connected to the rack was also filled with air and a small amount of solvent. The syringe had been properly primed, but air had entered the tubing for no apparent reason.However, the syringe fit the tubing properly, with no signs of wear or damage.This had already been observed last week, so we decided to file a report to inform the pharmacy so they can monitor the equipment closely and avoid causing complications for the patient.Here is the equipment potentially involved:50 mL Luer Lock syringe 300865,150 cm 3 valve tubing RNC3315A,150 cm PE linear extension tube PB3115M.Clarification via phone:The syringe was half full when the problem was discovered. The solution in the IV bag was Scoburen. The patient was also receiving M
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817523 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773792 ↗MalfunctionSep 11, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744625 ↗MalfunctionSep 10, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724946 ↗MalfunctionSep 8, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675483 ↗MalfunctionSep 4, 2026Dent in Material
No additional information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50621027 ↗MalfunctionSep 2, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576824 ↗MalfunctionSep 2, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576823 ↗MalfunctionSep 2, 2026Physical Resistance/Sticking
No additional information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576821 ↗MalfunctionAug 17, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280958 ↗MalfunctionAug 11, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50204057 ↗MalfunctionJul 27, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022146 ↗MalfunctionJun 26, 2026Difficult to Flush; Infusion or Flow Problem; Air/Gas in Device
THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FAILURE TO ADMINISTER MEDICATION TO THE PATIENT DURING SURGERY AND CONNECTION TO A SYRINGE PUMP. WHEN DID THE INCIDENT OCCUR? DURING USE. IT WAS REPORTED THAT AFTER CONNECTING A 50 ML SYRINGE TO A SYRINGE PUMP AND INITIATING NOREPINEPHRINE INFUSION, A SIGNIFICANT AMOUNT OF AIR WAS DETECTED IN THE SYRINGE, PREVENTING DELIVERY OF THE DRUG TO THE PATIENT DURING SURGERY. ADDITIONAL INFORMATION PROVIDED: RESPONSE RECEIVED ON (B)(6) 2026 5:58 PM (B)(6). WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25634958 ↗MalfunctionMay 27, 2026Contamination
THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT: I AM EMAILING REGARDING A RECENT BATCH OF 50ML SYRINGES. UPON OPENING THE SYRINGES, WE HAVE IDENTIFIED AN EXCESS OF WHAT SEEMS TO BE OIL RESIDUE IN THE SYRINGES. WE USE YOUR SYRINGES TO MANUFACTURE SACT, MAB AND CIVA TREATMENTS. WHEN DID THE INCIDENT OCCUR? BEFORE USE. SHORT DESCRIPTION: UPON OPENING THE SYRINGES, IDENTIFIED AN EXCESS OF WHAT SEEMS TO BE OIL RESIDUE IN THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310789 ↗MalfunctionMay 11, 2026Contamination
IT WAS REPORTED THAT THE BD SYRINGE 50ML LL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE FOLLOWING WAS REPORTED: PLEASE FIND ATTACHED A MEDICAL DEVICE VIGILANCE REPORT FROM THE (B)(6) HOSPITAL. WE KINDLY REQUEST THAT YOU FORWARD TO US THE INVESTIGATION REPORT¿SHOULD ONE BE REQUESTED BY THE ANSM¿OR YOUR CONCLUSIONS REGARDING THIS INCIDENT. THE DEVICE IN QUESTION IS AVAILABLE FOR YOUR INSPECTION AT OUR UNIT. IF YOU WISH TO ANALYZE IT, YOU MAY SEND US SUITABLE PACKAGING FOR ITS RETURN TO THE FOLLOWING ADDRESS: REFERENCE: (B)(4). LOT: 2601107. IT WAS REPORTED THAT ON (B)(6) 2026 PRESENCE OF PLASTIC PIECES DETACHING FROM THE LUERS OF 50 ML SYRINGES USED FOR EPS AND PCA. ACTIONS UNDERTAKEN IN THE PLANT: DEVICE NOT RETAINED. PHOTOS AVAILABLE. A NEW UNIT WAS RETAINED. PLASTIC DEBRIS APPEARS TO BE PRESENT AT INSIDE THE PACKAGE, MORE OR LESS ATTACHED TO THE BARREL. RISK OF VENOUS EMBOLISM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25144516 ↗MalfunctionApr 24, 2026Contamination
IT WAS REPORTED THAT THE BD SYRINGE 50ML LL HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DID THE INCIDENT OCCUR? BEFORE USE. A LUBRICATING FILM HAS FORMED ON THE PISTON, CREATING A THIN, CONTINUOUS LAYER OF LUBRICANT ON ITS SURFACE. THIS FILM HELPS REDUCE FRICTION BETWEEN THE PISTON AND THE SURROUNDING COMPONENTS, ENSURES SMOOTHER MOVEMENT DURING OPERATION, AND PROTECTS THE PISTON FROM EXCESSIVE WEAR AND POTENTIAL DAMAGE CAUSED BY METAL-TO-METAL CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24980389 ↗MalfunctionApr 23, 2026Contamination
IT WAS REPORTED THAT THE BD SYRINGE 50ML LL HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DID THE INCIDENT OCCUR? BEFORE USE A LUBRICATING FILM HAS FORMED ON THE PISTON, CREATING A THIN, CONTINUOUS LAYER OF LUBRICANT ON ITS SURFACE. THIS FILM HELPS REDUCE FRICTION BETWEEN THE PISTON AND THE SURROUNDING COMPONENTS, ENSURES SMOOTHER MOVEMENT DURING OPERATION, AND PROTECTS THE PISTON FROM EXCESSIVE WEAR AND POTENTIAL DAMAGE CAUSED BY METAL-TO-METAL CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24971267 ↗MalfunctionApr 22, 2026Contamination
IT WAS REPORTED THAT THE BD SYRINGE 50ML LL HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT LUBRICATING FILM HAS FORMED ON THE PISTON. WHEN DID THE INCIDENT OCCUR? BEFORE USE. A LUBRICATING FILM HAS FORMED ON THE PISTON, CREATING A THIN, CONTINUOUS LAYER OF LUBRICANT ON ITS SURFACE. THIS FILM HELPS REDUCE FRICTION BETWEEN THE PISTON AND THE SURROUNDING COMPONENTS, ENSURES SMOOTHER MOVEMENT DURING OPERATION, AND PROTECTS THE PISTON FROM EXCESSIVE WEAR AND POTENTIAL DAMAGE CAUSED BY METAL-TO-METAL CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960548 ↗MalfunctionApr 10, 2026Infusion or Flow Problem
IT WAS REPORTED THAT THE BD SYRINGE 50ML LL PLUNGER MOVEMENT WAS DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WE HAVE IDENTIFIED AN ISSUE WITH SYRINGE 300865, A 50/60 ML LUER-LOCK SYRINGE FOR SYRINGE PUMPS, WHICH IS COVERED BY OUR CONTRACT WITH YOU FOR INJECTIONS AND INFUSIONS. OUR ANAESTHESIA TEAM IN THE OPERATING THEATRE HAS ENCOUNTERED ISSUES WHEN USING IT, AS THE PUMP ISSUES AN OCCLUSION WARNING WHEN ADMINISTERING THE INDUCTION DOSE DURING ANAESTHESIA VIA TCI, AND THE FLOW RATE RISES TO AS HIGH AS 800 ML/HOUR. THIS HAS NOW OCCURRED ON SEVERAL OCCASIONS WITH AT LEAST TWO DIFFERENT BATCHES: LOT NO. 2505127, LOT NO. 2507114. ADDITIONAL INFORMATION PROVIDED: IT WAS MENTIONED AS SEVERAL OCCASIONS. COULD YOU PLEASE PROVIDE THE DATE OF EVENT? APPROX FROM 11/3 TO TODAY. HAS THERE BEEN ANY PATIENT IMPACT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE OF TREATMENT REQUIRED)? NO PATIENT IMPACT HAS BEEN REPORTED. BUT EXTRA EFFORT HAS BEEN NEEDED TO SECURE THAT THE PATIENT GET THE CORRECT AMOUNT OF ANAESTHESIA MEDICATION. WHAT PUMP WAS BEING USED? B. BRAUN SPACE PLUS. PLEASE CLARIFY WHICH DATE REFERS TO WHICH LOT#(S). THE PROBLEM HAS OCCURRE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844860 ↗
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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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