MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB; PISTON SYRINGE

Catalog Number	305540
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field 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 allergy 1ml w/ndl 27x1/2 rb needle went through the shield.The following information was provided by the initial reporter: material # 305540 , batch # 5097095.Verbatim: rcc received a complaint via email.Email(s) attached.I wasn't sure if i let you know or if you know who i reached out to but i had an incident in the past that has now happened again.It might be a defect in the order but i wanted to bring it to someone attention since it's the second time.One of our needles was sticking out of the top, i have attached pictures for reference.I¿m not sure if this is a business unit that you can help with but i need someone to get in touch with regarding issues my customer is having.This isn¿t the first incident they¿ve experienced with broken needles from the bd allergy trays.I¿ve included the photos they sent me.If you¿re able to help me get them working product that would be great, or get me in contact with who can help! the customer experienced with broken needles from the bd allergy trays.Item# 305540.Lot# 5097095.
Additional Manufacturer Narrative
2 photos were received and analyzed by our quality team with the customer's complaint of needle through shield.The photos are enough to verify the failure but without a physical sample for investigation, the root cause remains unknown.Multiple attempts were made to acquire the device production history but due to plant closure the records could not be obtained.If there were quality alerts or abnormalities for this lot# these would be evident and reported.In this case quality defects in this lot are unlikely.
Event or Problem Description
Photos.

• Brand Name: BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): EMBECTA MEDICAL I LLC; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): EMBECTA MEDICAL I LLC; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23020343
• Report Number: 2243072-2025-01145
• Device Sequence Number: 15839366
• Product Code: FMF
• UDI-Device Identifier: 00382903055401
• UDI-Public: (01)00382903055401(17)300430(10)5097095
• 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): 12/16/2025

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: 305540
• Device Lot Number: UNKNOWN
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown