MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 5ML S/T SSU NRFIT; PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT

Catalog Number	400051
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
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 was reported that the bd syringe 5ml s/t ssu nrfit stopper was defective / damaged.The following information was provided by the initial reporter: before use, when they took the syringe out of the package and were about to draw up the medicine, they saw that the black membrane looked "melted" and lay at an angled angle into the syringe.They never had time to use the syringe but saw the defect before the drug began to be withdrawn.
Additional Manufacturer Narrative
One sample of a 5 ml s/t ssu nrfit syringe (part number 400051, batch 3117599) was received for invetsigation.The sample arrived loose and fully assembled.Upon inspection, it was observed that the stopper was significantly distorted, which compromises the functionality and reliability of the syringe.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.The potential root cause for the distorted stopper defect is associated with the assembly process.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD SYRINGE 5ML S/T SSU NRFIT
• Common Device Name: PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20768678
• Report Number: 1213809-2024-00877
• Device Sequence Number: 14555965
• Product Code: QEH
• UDI-Device Identifier: 00382904000516
• UDI-Public: (01)00382904000516(11)230427(17)280430(10)3117599
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K192538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: 400051
• Device Lot Number: 3117599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 11/24/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown