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 Patient Involvement (2645)
Date of Event	10/22/2020
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 needle vented nokor 16x1 tw had foreign matter.The following information was provided by the initial reporter: material no.: 305213 batch no.: 0143230.It was reported that there was flashing and angel hair.
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was performed for provided lot number 143230.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, the samples from a similar complaint were used in the investigation.One photo was provided.The photo shows a needle assembly with plastic flash at the bottom part of the plastic needle hub.Additionally, 1000 samples were received and the samples came in 10 shelf boxes of 100 each.A visual inspection was performed, the needle hub flash was confirmed.The cause for this defect could have resulted from an issue from the mold the mold and the defective sample was not detected during the molding inspections and the next processes.
Event or Problem Description
It was reported that needle vented nokor 16x1 tw had foreign matter.The following information was provided by the initial reporter: material no.: 305213 batch no.: 0143230 it was reported that there was flashing and angel hair.

• 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: 10865146
• Report Number: 1911916-2020-01044
• Device Sequence Number: 2465433
• 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,Followup
• Report Date (Section B): 11/21/2020

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: 07/31/2025
• Device Model Number: 305213
• Device Catalogue Number: 305213
• Device Lot Number: 0143230
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 11/21/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1