MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	306547
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It is reported that the syr 10ml pump compatible saline 10ml fil barrel / flange is damaged.The following information was provided by the initial reporter: incident details: three medfusion 4000 syringe pumps have come down to clinical engineering in a short time frame all reporting the same problem: ¿syringe plunger not in place¿ with an arrow pointing to a representation of the syringe barrel flange.M333717, m333711, m909775 a work order dated 09-dec-2025 was found documenting the problem; the pump subsequently came back to ce with the same issue recently.No faults were found with the pumps when bench tested.This appears to be an issue with prefilled 10ml bd syringes.Some 10ml bd syringes have been found to have narrower flanges.(1.5mm vs 2.0mm).Staff could be informed that repositioning the barrel can alleviate the problem, or the syringes with the narrow flanges removed from circulation.No serious harm was reported.Unfortunately, the device is not available for investigation.Additional information provided: in none of the cases the syringes were supplied to clinical engineering for analysis.However, finding our own prefilled 10ml for testing resulted in the same error ¿ it was marked lot: 2028-01-31 5024175.It measures 1.55mm, whereas non-prefilled 10ml bd c-199 (no lot number) measures 2.01 ¿ 2.07mm.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: a complaint history check was not performed as the lot number is unknown for this complaint.A device history record review was not performed as the lot number is unknown for this complaint.A review of the applicable risk document indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.The root cause was not concluded due to unavailability of batch information.

• Brand Name: BD POSIFLUSH
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24101219
• Report Number: 1911916-2026-00014
• Device Sequence Number: 10469469
• Product Code: FOZ
• UDI-Device Identifier: 00382903065479
• UDI-Public: (01)00382903065479
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K003553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 306547
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown