MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK; PISTON SYRINGE

Catalog Number	309605
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
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 was reported that the bd syringe 10ml ll tip bulk convenience pak barrel cracked.The following information was provided by the initial reporter: material #309605 lot #5241727.Verbatim: rcc received a complaint via phone.Customer states that they had some of the 10ml luerlock syringes crack.Customer has product to return if needed.Customer did not have the product number or the certain lot number but they did have the lot number that they have onsite (not sure if it's the same lot that cracked).Lot number 5241727,309605.Additional information provided: to follow up, we had more cracking.I was also informed by my tech that they have been finding them cracked before they even use them, it is usually 1-2 from each box of the 20 syringes.New lot number: 5260078.Additional information received on 10/29/2025: majority was during use however one of my techs has mentioned that she seen some broken prior to use.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported that some syringes exhibited cracks.To support the investigation, two samples of 10 ml luer-lok syringes were received for evaluation by the quality team.Both samples arrived loose and showed cracks in the barrel¿one measuring approximately 1¼ inches in length and the other 1½ inches.This condition is non-conforming to product specifications and appears to be associated with the assembly process.A review of the device history record was conducted for material number 309605, lot 5241727.The review confirmed that all visual inspections were performed in accordance with requirements, and no quality notifications were identified related to the reported condition.The lot was inspected and accepted based on the inspection control plan, approved for shipment, and deemed compliant with product specification requirements.To date, no other similar events have been reported for this lot.

• Brand Name: BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK
• Common Device Name: PISTON SYRINGE
• 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: 23475682
• Report Number: 1213809-2025-00700
• Device Sequence Number: 13369813
• Product Code: FMF
• UDI-Device Identifier: 30382903096054
• UDI-Public: (01)30382903096054(17)300731(10)5241727
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 309605
• Device Lot Number: 5241727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown