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	10/16/2020
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 issues during the production process that could have induced this reported defect.To aid in the investigation, one thousand physical samples were received.They came in ten shelf boxes with one hundred samples each.Visual inspection was performed, the needle hub flash was confirmed and no other defect was observed.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 and the next processes.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.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.Investigation conclusion: based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.We will continue monitoring the complaints of this product and lot.It could be possible one of the cavities of the mold had an issue and was not detected during the molding inspections and the next processes.
Event or Problem Description
It was reported that the needle vented nokor 16x1 tw experienced foreign matter contamination.The following information was provided by the initial reporter: material no.: 305213 batch no.: 0143230.We received again a rejection for this part: po (b)(4) (replacement order) - part# 5032a (305213) - r094420 ¿ lot# 0143230 reason: flashing and angel hair.All the 5 shipments received had to be returned to this matter and this is a different lot number.

• 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: 10825033
• Report Number: 1911916-2020-01023
• Device Sequence Number: 16794563
• 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): 10/30/2020

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: 10/16/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1