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

Catalog Number	305165
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that holes in the bd precisionglide¿ needle hub caused medication to leak out while drawing it up.The following information was provided by the initial reporter: "staff have noted what they feel to be ¿defectiveness¿ related to the bd precision glide needles 21gx1¿ (concordance item #113936) lot 2244944.Few and far between, but have been noticing holes in the side of the needle hub which causes medications to leak out during draw up.".
Event or Problem Description
It was reported that holes in the bd precisionglide¿ needle hub caused medication to leak out while drawing it up.The following information was provided by the initial reporter: "staff have noted what they feel to be ¿defectiveness¿ related to the bd precision glide needles 21gx1¿ (concordance item #113936) lot 2244944.Few and far between, but have been noticing holes in the side of the needle hub which causes medications to leak out during draw up.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 07-feb-2023.H6: investigation summary: it was reported there were holes on side of the needle hub that cause leakage when drawing medication.To aid in the investigation, one sample in an opened packaging blister was received for evaluation by our quality team.A visual inspection was performed.First, with a 10x magnification lens, and then with a 30x microscope.No defects or imperfections were observed.The sample was then connected to a syringe with saline solution.No leakage occurred.A device history record review was completed for provided material number 305165, lot 2244944.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be determined.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16269581
• Report Number: 1911916-2023-00045
• Device Sequence Number: 7435303
• Product Code: FMI
• UDI-Device Identifier: 00382903051656
• UDI-Public: 00382903051656
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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: 305165
• Device Lot Number: 2244944
• 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: 01/11/2023
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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