MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL PrecisionGlide; Needle, Hypodermic, Single Lumen

Catalog Number	305197
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, needle 16x1 rb, broken needle hub during use.The following was provided by the initial reporter: at our hospital we have had several instances of needles breaking apart when the needle is being injected into a vial.The needle is the bd precision glide needle 16g x 1" lot number 6175332, exp 5/31/2031.Additional information: can you please provide an exact date of event in format dd-mmm-yyyy? (b)(6)2026 and (b)(6)2026.As you mentioned "we have had several instances" were there any events that were not reported to bd earlier? if yes kindly provide further details of the events not reported before.Several events happened t september 7th, however this was not reported to me until another event on september 14th.He week of.
Additional Manufacturer Narrative
B3.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

• Brand Name: 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 ; +1(847)393-5694
• MDR Report Key: 50870805
• Report Number: 1911916-2026-00513
• Device Sequence Number: 16138115
• Product Code: FMI
• UDI-Device Identifier: 00382903051977
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 305197
• Device Lot Number: 6175332
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown