MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML S/T W/NDL 27X3/8 IB; PISTON SYRINGE

Catalog Number	303344
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
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 1ml s/t w/ndl 27x3/8 ib needle went through the shield.The following information was provided by the initial reporter: material#: 303344, batch#: 3117445.Rcc received a complaint via email.Two different 1ml (27g) tb syringes were defective in the same lot.One syringe, had the needle bent and was completely exposed outside the cap (the needle went through the side of the cap) in the secured package.The other syringe had the needle slightly bent (it did not pierce the cap) however, the actual cap was broken and didn't fit securely over the needle.The syringes were never exposed to the patient - the defects were identified before pt contact occurred.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.It was reported that one needle was bent and completely exposed outside the cap within the secured package, while the other needle was slightly bent but did not pierce the cap.Additionally, the cap itself was broken and did not fit securely over the needle.To support the investigation, one sample in an opened blister package, assembled to a 1ml syringe, was received for evaluation by the quality team.A visual inspection was performed, and the needle assembly showed no defects or imperfections.The needle was straight, and the plastic shield exhibited no damage.A review of the device history record was completed for material number 303344, batch 3117445.The review confirmed that all visual inspections were performed according to requirements, with no quality notifications related to the reported condition.The lot was inspected and accepted based on the inspection control plan and subsequently approved for shipment.Additional device history records were reviewed for each batch of needles used in manufacturing this final batch, and no documentation indicated this type of defect during the entire production run.To date, no similar events have been reported for this lot.Based on the investigation and analysis of the returned sample, the reported issue could not be confirmed.

• Brand Name: BD SYRINGE 1ML S/T W/NDL 27X3/8 IB
• 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: 23285887
• Report Number: 1213809-2025-00648
• Device Sequence Number: 14820333
• Product Code: FMF
• UDI-Device Identifier: 00382903033447
• UDI-Public: (01)00382903033447(17)280430(10)3117445
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 303344
• Device Lot Number: 3117445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown