MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK LUER-LOK; SYRINGE, PISTON

Catalog Number	305060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2026
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 bd syringe 3ml ll w/ndl 18x1-1/2 blunt fil had a needle defect.We have received a quality complaint on product sold to our customer.Please contact the customer and cc xxx and xxx on any future communication.Injuries or adverse event: no, item: 305060, quantity affected: 1 cs, serial/lot number: (b)(6), po: (b)(4), are any samples available for return? yes.Reported issue: hey (b)(6), can you report this item ref - 305060 3 ml syringe ll blunt tip 18ga 1 lot#: 5317756, needle base broke during med draw.Customer disposition request: replacement.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation it was reported that the needle base fractured during medication withdrawal.To support the investigation, one sample with an opened blister package was received by the quality team for evaluation.A visual inspection was performed.The lower portion of the needle hub remained assembled to a 3ml syringe, while the upper portion of the needle assembly was retained within the plastic shield.The fracture surface appeared irregular, which is consistent with damage potentially induced by excessive force.No additional defects or abnormalities were observed.A device history record (dhr) review was completed for material number 305060, lot 5317756.The review confirmed that all required visual inspections were performed in accordance with established requirements, and no quality notifications were identified related to the reported condition.The lot was inspected and accepted per the inspection control plan and subsequently released for shipment.In addition, device history records were reviewed for each needle lot used in the manufacture of the final lot.No evidence of this type of defect was documented throughout production of these lots.To date, no other similar complaints have been reported for lot 5317756.Based on the investigation, including evaluation of the returned sample, the customer reported condition is confirmed.

• Brand Name: BD PLASTIPAK LUER-LOK
• Common Device Name: SYRINGE, PISTON
• 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: 24916208
• Report Number: 1213809-2026-00208
• Device Sequence Number: 9111876
• Product Code: FMF
• UDI-Device Identifier: 00382903050604
• UDI-Public: (01)00382903050604
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: Other
• Device Catalogue Number: 305060
• Device Lot Number: 5317756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown