MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC BD ALLERGY SYRINGE; PISTON SYRINGE

Catalog Number	305540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe allergy 1ml w/ndl 27x1/2 rb needle pulled out of hub.Rcc received a complaint via email.Our customer reported an issue with item 305540.Please see below in red and advise next step.I were prepping injections, one of the needles stayed in the vial when withdrawing the syringe.Product allergy syringe tray 1ml 27gx1/2in (305540).Lot: 5129219.Exp: 2030-05-31.It was the last in this tray, we did not have this issue with any of the others.We do have trays with the same lot number.Mckesson po#: (b)(4).1/30/2026: 1 syringe from 1 unit unnecessary to ship back at this time.It was the last out of the box and the rest of the product worked correctly no patient harm, complications or negative outcomes occurred.The needle did pull completely out of the hub.There was no spinning and the connection did not seem loose when first inserted into the vial.
Additional Manufacturer Narrative
E.1.Address was not located, and il was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD ALLERGY SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): EMBECTA MEDICAL I LLC; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24474256
• Report Number: 2243072-2026-00133
• Device Sequence Number: 13157068
• Product Code: FMF
• UDI-Device Identifier: 00382903055401
• UDI-Public: (01)00382903055401(17)300531(10)5129219
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/29/2026

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: Other
• Device Catalogue Number: 305540
• Device Lot Number: 5129219
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown