MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 30ML LL TIP CONV PAK; PISTON SYRINGE

Catalog Number	305618
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 30 ml ll tip conv pak: foreign matter.It was reported by the customer that they discovered multiple syringes containing black particulate matter in the syringe barrel.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 11 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 ten of the samples had no defects or imperfections and in one of the syringes a particle measuring 1/32¿ and three particles measuring 1/64¿ could be observed embedded in the barrel of the syringe about 2 ¼¿ from the barrel flange.Embedded material can be caused by degraded resin in the molding process.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.

• Brand Name: SYRINGE 30ML LL TIP CONV PAK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23075133
• Report Number: 9610847-2025-00311
• Device Sequence Number: 11949182
• Product Code: FMF
• UDI-Device Identifier: 00382903056187
• UDI-Public: (01)00382903056187(17)300331(10)5112150
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/05/2025

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: 305618
• Device Lot Number: 5112150
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown