MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 50CC LL TIP CONVENIENCE PAK; PISTON SYRINGE

Catalog Number	309680
Medical Device Problem Codes	Contamination (1120); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 309680.Batch # 5160401,4246343.It was reported by customer that two 50ml syringes have internal defects: one has a white appearance other one has a black appearance.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 4 photos and 2 physical samples submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection and testing of the samples.Analysis of the sample showed that in one of the samples, a dark colored embedded speck was located at 1/2¿ from the bottom of the syringe barrel and the other sample there was an embedded speck that is located at 3 3/16¿ from the bottom of the syringe barrel.Bd determined that the cause of the failure was the molding process as embedded degraded resin occurs and can break loose and be molded into components.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: SYRINGE 50CC LL TIP CONVENIENCE PAK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23570665
• Report Number: 9610847-2025-00427
• Device Sequence Number: 15919754
• Product Code: FMF
• UDI-Device Identifier: 00382903096800
• UDI-Public: (01)00382903096800(17)300531(10)5160401
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/09/2026

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: 309680
• Device Lot Number: 5160401
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown