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	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
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
Material: 303344, lot: unknown.It was reported that the bd syringe 1ml s/t w/ndl 27x3/8 ib had a syringe needle connectivity issue.The following information was provided by the initial reporter: we are having some issues with this product.Our original#: 303327 is still on backorder it sounds like so we are using the #: 303344 as a sub.The issue that is being surfaced to us is that the needle is actually disconnecting from the syringe post-administration and is remaining stuck in the patients.I need to know if you have heard this happening elsewhere.
Additional Manufacturer Narrative
(b)(4) syringe needle connectivity issue.One photo was provided to our quality team for investigation.The image shows a fully assembled loose syringe and placed needle next to it without needle shield.No defects are observed in the provided photo.It is recommended to hand tighten the needle onto the syringe prior to use.A batch number and a physical sample is required for a more thorough evaluation and potential root cause determination.
Event or Problem Description
No additional information was provided.

• 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: 21469050
• Report Number: 1213809-2025-00137
• Device Sequence Number: 8840501
• Product Code: FMF
• UDI-Device Identifier: 00382903033447
• UDI-Public: (01)00382903033447
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 03/19/2025

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 03/21/2025
• 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