MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE CONTROL 10ML LL; PISTON SYRINGE

Catalog Number	309695
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One sample was provided to our quality team for investigation.Through visual inspection, it was observed that sample has severe damage to the plunger/ bent, which affect form, integrity, and functionality.The condition observed is non-conforming per product specification.The potential root cause for the damaged plunger defect is associated with the assembly process.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.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 was provided.
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
Material #:309695.Batch#: unknown.It was reported that the bd syringe control 10ml ll plunger rod bends easily.The following information was provided by the initial reporter: verbatim: rcc received a complaint via phone.Pir attached.309695.C-241-27.The plungers folded.Was used on a patient happened on (b)(6).Additional information provided: 1.Please provide the date of event.12/3/2024.2.Please provide the batch# or lot# number? package not available but product sent back to bd.3.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No patient harm but physician did receive a needle stick.

• Brand Name: BD SYRINGE CONTROL 10ML LL
• 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: 21066589
• Report Number: 1213809-2024-01022
• Device Sequence Number: 3417689
• Product Code: FMF
• UDI-Device Identifier: 30382903096955
• UDI-Public: (01)30382903096955
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/20/2025

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: 309695
• Device Lot Number: UNKNOWN
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown