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 Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: a device history record review was completed for provided material number 305213 and lot number 0143230.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows the needle assembly with plastic flash at the bottom part of the needle hub.Investigation conclusion: based on the investigation with the photo sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Root cause description: it could be possible for this defect to occur if one of the mold cavities had an issue that was not detected during the molding inspections or in the next processes.Rationale: further action has not been determined necessary at this time.
Event or Problem Description
It was reported that needle vented nokor 16x1 tw had foreign matter on the needle.This occurred on 2 occasions.The following information was provided by the initial reporter: material no.: 305213 batch no.: 0143230.It was reported that flashing was observed on the needle.

• 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: 10961875
• Report Number: 1911916-2020-01102
• Device Sequence Number: 13628899
• 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): 11/20/2020

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: 07/31/2025
• Device Model Number: 305213
• Device Catalogue Number: 305213
• Device Lot Number: 0143230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1