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

Model Number	305167
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default 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 that bd precisionglide¿ needle had a hole in the needle hub that led to leakage.The following information was provided by the initial reporter: "there is a hole in the green plastic part of the needle and when you try and pull solvents it is leaking out of the hole.".
Additional Manufacturer Narrative
H.6.Investigation: it was reported there is a hole in the green plastic part of the needle.To aid in the investigation, five samples in sealed packaging blisters were received for evaluation by our quality team.A visual inspection was performed, first with a 10x magnifier lens, and then with a 30x microscope.The needle hub has an imperfection 1/4" from the bottom part.The imperfection did not go through the wall of the needle hub.Each sample was then connected to a syringe with saline solution.No leakage occurred.No other defects or imperfections were observed.It could be possible during the needle hub molding process that an imperfection was created.A device history record review was completed for provided material number 305167, lot number 1026976.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.
Event or Problem Description
It was reported that bd precision glide¿ needle had a hole in the needle hub that led to leakage.The following information was provided by the initial reporter: "there is a hole in the green plastic part of the needle and when you try and pull solvents it is leaking out of the hole.".

• 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: 13454678
• Report Number: 1911916-2022-00056
• Device Sequence Number: 6009547
• Product Code: FMI
• UDI-Device Identifier: 30382903051671
• UDI-Public: 30382903051671
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/07/2022

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 Expiration Date: 03/31/2026
• Device Model Number: 305167
• Device Catalogue Number: 305167
• Device Lot Number: 1026976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2021
• 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