MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305107
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 needle 30ga 1/2in had leakage.The following information was provided by the initial reporter: when removing the needle and placing it in the syringe, liquid was observed leaking from one of the sides of the needle in its proximal area.Outcome of the event: there was no harm to the patient or to the staff who handled the medical device is the device available for evaluation? no detection of the adverse event/incident: during use of the md date of the adverse event/incident: 06/16/2025 indicate whether the medical device has been used more than once: no name of medical device: hypodermic needle 30g x 1/2 (0.3mm x 13mm) batch: 4060069 model: ref: 305107 initial diagnosis of the patient: d485-tumor of uncertain or unknown behavior of the skin.Additional information received on 03sep2025 email follow up: - could you please send photo samples/videos of the sample? we do not have photographic evidence as the device was discarded by the institution.
Additional Manufacturer Narrative
(b)(4) follow up.A device history record review was completed by our quality engineer team for provided material number 305107 and lot number 4060069.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.

• Brand Name: BD PRECISIONGLIDE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 23080228
• Report Number: 1911916-2025-00642
• Device Sequence Number: 18571806
• Product Code: FMI
• UDI-Device Identifier: 00382903051076
• UDI-Public: (01)00382903051076(17)290531(10)4060069
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: 305107
• Device Lot Number: 4060069
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female