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 Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: a device history record review was performed for provided lot number 9350665.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this incident, one physical sample and one picture sample was received.The physical sample is a set of 5 sealed packaging blisters.A visual inspection was performed and the set of 5 packaging blisters have the proper slitting.The sample in the middle is a purple needle hub, the other 4 are gray.The picture sample shows the samples received.Investigation conclusion: based on the investigation and with the sample and photo sample analysis the symptom reported by the customer is confirmed.We will continue monitoring the complaint trend for the product and symptom.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.Root cause description: the cause for this defect could have resulted when the mixed unit was left in the needle feeder form the previous lot and the label went undetected.Rationale: further action has not been determined necessary at this time.
Event or Problem Description
It was reported that needle 27ga 1-1/2in came with a mix of product types.The following information was provided by the initial reporter: material no.: 301629 batch no.: 899538.It was reported that incorrect needle was in sealed packaging.

• 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: 11095318
• Report Number: 1911916-2020-01150
• Device Sequence Number: 897478
• Product Code: FMI
• UDI-Device Identifier: 30382903016298
• UDI-Public: 30382903016298
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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: 02/28/2025
• Device Model Number: 301629
• Device Catalogue Number: 301629
• Device Lot Number: 9350665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1