MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 27GA 1-1/2IN; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	301629
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 2 needles 27ga 1-1/2in contained foreign matter.The following information was provided by the initial reporter: "it was reported that needle had a white substance and is disfigured.Verbatim: consumer reported found 2 needles with discolored/white substance that is disfigured too.Lot #: 8331594, catalog #: 301629.Date of event (b)(6) 2020: discard this 1 needle same issue.Date of event (b)(6) 2020: sending this sample back same issue.Sample status awaiting sample".
Event or Problem Description
It was reported that 2 needles 27ga 1-1/2in contained foreign matter.The following information was provided by the initial reporter: "it was reported that needle had a white substance and is disfigured.Verbatim: consumer reported found 2 needles with discolored/white substance that is disfigured too.Lot # 8331594, catalog# 301629, date of event 09/18/2020 - discard this 1 needle same issue, date of event 09/22/2020 sending this sample back same issue, sample status awaiting sample.".
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot number 8331594.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.

• Brand Name: NEEDLE 27GA 1-1/2IN
• 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: 10687588
• Report Number: 1911916-2020-00958
• Device Sequence Number: 16941054
• Product Code: FMI
• UDI-Device Identifier: 30382903016298
• UDI-Public: 30382903016298
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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 Expiration Date: 01/31/2024
• Device Model Number: 301629
• Device Catalogue Number: 301629
• Device Lot Number: 8331594
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 10/26/2020
• 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