MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 20ML LL S/C 48; SYRINGE, PISTON

Catalog Number	302830
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported by customer that black strip on back of packaging, when separated noted that not sealed where black strip is present representing concern for sterility.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation: it was reported that the package appeared unsealed where a black strip was present.To support the investigation, four sealed blister pack samples and one photograph were received for evaluation by the quality team.A visual inspection was performed.The blister package top web contained a dark colored tape used as a splice on the top web.The photograph corresponded to the samples received.No additional defects or imperfections were observed.This condition can occur when spliced product is not removed from the manufacturing process.A device history record review was completed for material number 302830, lot 5308426.The review did not reveal any detected quality issues during production that could have contributed to the reported condition, and there were no related quality notifications.All processes and final inspections met specification requirements.The samples will be shared with associates for awareness.To date, no similar events have been reported for this lot.Based on the investigation and the returned sample analysis, the customer reported condition is confirmed.

• Brand Name: SYRINGE 20ML LL S/C 48
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24304579
• Report Number: 1911916-2026-00062
• Device Sequence Number: 9679618
• Product Code: FMF
• UDI-Device Identifier: 00382903028306
• UDI-Public: (01)00382903028306(11)251106(17)301031(10)5308426
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/19/2026

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: Health Professional
• Device Catalogue Number: 302830
• Device Lot Number: 5308426
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown