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

Catalog Number	305540
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe allergy 1ml w/ndl 27x1/2 rb contained foreign matter.Rcc received a complaint via email.Injuries or adverse event: no item: 305540 quantity affected: 1cs serial/lot number: n/a po: (b)(4) are any samples available for return? yes are samples potentially contaminated or biohazard? n/a.Reported issue: cst ordered needles and states tried to use ne and the tip has red and looks sticky called ps and they suggested to not use the needles since they arent individually packaged.She states it could be melted glue, unsure of sustance.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
37 trays of material# 305540 syringes plus 91 loose syringes including the 1 affected sample were received and analyzed by our quality team with the customer's complaint of foreign matter.The affected sample was visually analyzed and the red-pastey substance was immediately confirmed near needle base.The customer's complaint of foreign matter was verified.The red substance is a machine lubricant that aids in syringe assembly machinery.The root cause of this issue is over application of machine lubricant and a subsequent quality control deficiency that failed to segregate the change affected material.Corrective action is not available due to plant closure.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.
Event or Problem Description
Sample.

• 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: 23978417
• Report Number: 2243072-2025-01559
• Device Sequence Number: 18798252
• Product Code: FMF
• UDI-Device Identifier: 00382903055401
• UDI-Public: (01)00382903055401(17)300630(10)5160332
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/20/2026

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: 5160332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2025
• 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