MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE VENTED NOKOR 16X1 TW; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number	305213
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.(b)(4).Investigation summary: a device history record review was performed for provided lot number 9322472.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, 1000 physical samples and a picture sample was received for evaluation by our quality team.Through examination of the samples, a visual inspection was preformed and the needle hub flash was confirmed to have a molding defect.In response to this incident, the defective samples were taken to be shown to the molding coordinator, mold techs and inspectors.Investigation conclusion: our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.Root cause description: the cause of this defect could have resulted from the cavity of the mold, causing the defect, and going unnoticed during inspection.
Event or Problem Description
It was reported that needle vented nokor 16x1 tw had a molding defect.This occurred on 1000 occasions before use.The following information was provided by the initial reporter: material no.: 305213 batch; no.: 9322472.It was reported that needles were found with flashing.

• Brand Name: NEEDLE VENTED NOKOR 16X1 TW
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10571370
• Report Number: 1911916-2020-00894
• Device Sequence Number: 3028749
• Product Code: GAA
• UDI-Device Identifier: 00382903052134
• UDI-Public: 00382903052134
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 09/08/2020

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: 03/31/2025
• Device Model Number: 305213
• Device Catalogue Number: 305213
• Device Lot Number: 9322472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/23/2020
• 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