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

Catalog Number	305109
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 3 of the bd precisionglide¿ needle had foreign matter.The following was received from the initial reporter: 1 unit of dirty needle.2 units of dirty needles.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported there were multiple defects with product received.To aid in the investigation, eleven samples in sealed packaging blisters were received for evaluation by our quality team.Eight samples were from lot 2244830, two samples were from lot 2222581 and one sample was from lot 2020910.A visual inspection was performed.Five samples were empty packaging blisters, two samples had only the plastic shield, one packaging blister has two needle assemblies in it, one unit has foreign matter at the bottom of the needle hub and two samples had no defects or imperfections.These defects could occur if there is a jam at the feeder during the packaging process.A device history record review was completed for provided material number (b)(4), lots 2244830, 2222581 and 2020910.The review did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.The samples will be shown to associates for awareness.To date, there have been no other similar events reported for these lots.Based on the investigation and with the returned sample analysis the symptoms reported by the customer is confirmed.
Event or Problem Description
No additional information received.It was reported that 3 of the bd precisionglide¿ needle had foreign matter.The following was received from the initial reporter: 1 unit of dirty needle.2 units of dirty needles.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17916710
• Report Number: 1911916-2023-00763
• Device Sequence Number: 17841299
• Product Code: FMI
• UDI-Device Identifier: 30382903051091
• UDI-Public: (01)30382903051091
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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: 305109
• Device Lot Number: 2244830
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/01/2023
• 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