MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL CAP TIP SYR LL/LS STER LF PP BLUE SINGLE; CONTAINER, LIQUID MEDICATION, GRADUATED

Catalog Number	305819
Medical Device Problem Codes	Volume Accuracy Problem (1675); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed liquid present inside the tip cap.Additional information there was no patient harm as this was caught by a pharmacist and subsequently the tip cap was changed to an alternative tip cap before dispensing.
Additional Manufacturer Narrative
H3: 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
Additional information: for a small dose such as this medication at 0.2 ml, there could be greater than 10% of fluid loss in the headspace of the blue tip cap, which can potentially underdose a patient if this were a more critically impactful medication.
Additional Manufacturer Narrative
(b)(4) follow up.A report was received indicating fluid loss in the headspace of the blue tip cap.To support the investigation, two photographs were provided to the quality team for evaluation.The images depict a vial with two syringes positioned on either side, each fitted with a blue tip cap.No additional details could be confirmed from the photographs.The purpose of the tip cap is to protect the syringe luer connection.A device history record review was performed for material number 305819, lot 5353564.The review identified no manufacturing or inspection issues that would have contributed to the reported condition, and no related quality notifications were associated with this lot.All production activities and final inspections met applicable specification requirements.To date, no other similar events have been reported for this lot.Based on the investigation and the available photographic evidence, the condition described by the customer could not be confirmed.
Event or Problem Description
There was no patient harm.

• Brand Name: CAP TIP SYR LL/LS STER LF PP BLUE SINGLE
• Common Device Name: CONTAINER, LIQUID MEDICATION, GRADUATED
• 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: 24649429
• Report Number: 1911916-2026-00129
• Device Sequence Number: 15994611
• Product Code: KYW
• UDI-Device Identifier: 00382903058198
• UDI-Public: (01)00382903058198(10)5353564
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K911638
• 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,Followup
• Report Date (Section B): 03/31/2026

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: 305819
• Device Lot Number: 5353564
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 03/31/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown