MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD Plastipak Luer-Lok; Piston syringe

Catalog Number	300865
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: it was reported that several syringes were damaged and leaking multiple photos, videos, and seven physical samples were provided to our quality team for investigation.Upon evaluation, damage was identified between the 30 ml and 40 ml markings on all of the returned products, verifying the reported concern.A device history review was performed for the reported lot.No deviations or non-conformances were identified during the manufacturing process that could have contributed to this observation.Products from this manufacturing line are routinely sampled and subjected to visual and functional inspections throughout production in accordance with established procedures.No issues related to the reported concern were identified during these inspections.Sixty retained samples from the reported lot were used for additional evaluation.All products were inspected, and no damage or defects were observed on any of the devices.While a direct cause could not be identified, the observed damage was determined to have occurred during movement within the manufacturing equipment during the assembly process.To date, there have been no other similar events reported for this lot.Manufacturing personnel have been notified of this incident to reinforce awareness.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.

• Brand Name: BD Plastipak Luer-Lok
• Common Device Name: Piston syringe
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50621027
• Report Number: 3003152976-2026-00409
• Device Sequence Number: 18807396
• Product Code: FMF
• UDI-Device Identifier: 00382903008650
• UDI-Public: (01)00382903008650(11)260521(17)310430(10)2605079
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: See H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: 300865
• Device Lot Number: 2605079
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/02/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown