MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC BD SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB; PISTON SYRINGE

Catalog Number	305500
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located and (b)(6) was used.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 28x1/2 rb needle went through the shield.The following information was provided by the initial reporter: material # 305500 batch # 0069100.It was reported by the customer that patient was stuck by the needle while pulling it out of the package.The needle was sticking out of the gray cover that's supposed to cover the needle.Rcc received a complaint via email.Item(s): 305500, lot(s): 0069100d, date incident occurred: (b)(6) 2025.Was the patient impacted? if yes, describe: yes, patient was stuck by the needle while pulling it out of the package.The needle was sticking out of the gray cover that's suppose to cover the needle.Is a sample available? yes customer request? customer would like replacement needle.
Additional Manufacturer Narrative
Investigation summary: one needle was received and tested by our quality team with the customer's complaint of needle through shield.The needle was protruding through shield and complaint was verified.The shield and needle were analyzed under microscope and the manufacturer of the product was contacted for further investigation.The root cause of this issue is most likely due to operator error leading to improper alignment at time of cap and needle assembly.This is the first instance for this lot or for the material and corrective action is not necessary.
Event or Problem Description
Sample.

• Brand Name: BD SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB
• 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: 22779052
• Report Number: 2243072-2025-00979
• Device Sequence Number: 9487835
• Product Code: FMF
• UDI-Device Identifier: 00382903055005
• UDI-Public: (01)00382903055005(10)0069100
• 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: Company Representative
• 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: Lay User/Patient
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 305500
• Device Lot Number: 0069100
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown