MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 30GA 7/8IN BSG CLEAR HUB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	302890
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 8 needles 30ga 7/8in bsg clear hub experienced leakage prior to use.The following information was provided by the initial reporter: material no.302890 batch no.9294128.Please be aware that we have rejected the following lot due to drip over greater than 1/8" from the needle to the plastic hub flowing thru the plastic hub ribs.Non-conformance detected: 8 samples have a drip over of about 1/8" that starts from the area where the needle and the plastic hub joins flowing to the plastic hub ribs.These are not acceptable.Per ansi z1.4 level ii normal aql 0.65 performed this lot will be considered rejected.
Additional Manufacturer Narrative
H.6.Investigation summary one photo was provided for evaluation.It shows four needle assemblies.The parts have what appears drip over on the plastic hub.A potential root cause can be attributed to the needle assembly process.The plastic hub is placed under the cannulator; then, the needle is positioned and assembled to the plastic hub adding the white epoxy to fix it; after that, a plastic hub is assembled.In this case, a jam may have occurred at the cannulator inducing the excess of white epoxy on the needle hub.Based on the investigation and photos provided, the symptom reported by the customer is confirmed.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.
Event or Problem Description
It was reported that 8 needles 30ga 7/8in bsg clear hub experienced leakage prior to use.The following information was provided by the initial reporter: material no.(b)(6)batch no.9294128 please be aware that we have rejected the following lot due to drip over greater than 1/8" from the needle to the plastic hub flowing thru the plastic hub ribs.Non-conformance detected: 8 samples have a drip over of about 1/8" that starts from the area where the needle and the plastic hub joins flowing to the plastic hub ribs.These are not acceptable.Per ansi z1.4 level ii normal aql 0.65 performed this lot will be considered rejected.

• Brand Name: NEEDLE 30GA 7/8IN BSG CLEAR HUB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10254456
• Report Number: 1911916-2020-00638
• Device Sequence Number: 16854523
• Product Code: FMI
• UDI-Device Identifier: 50382903028905
• UDI-Public: 50382903028905
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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 Model Number: 302890
• Device Catalogue Number: 302890
• Device Lot Number: 9294128
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other