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	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation: a device history record review was completed for provided material number 305213 and lot number 9322472.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 thousand physical samples and one photo was received for evaluation by our quality team.The samples came in ten shelf boxes with one hundred samples in each box.A visual inspection was performed and the needle hub flash was observed.The photo provided shows a needle assembly with the needle hub plastic flash.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 in the next processes.
Event or Problem Description
It was reported that 1000 bd needle vented nokor 16x1 tw were found to be damaged/deformed before use.The following was reported by the initial reported: "it was reported that 1 case were found with flashing needles.Per attached email: unfortunately we received another rejection for bd# 305213 ¿ busse#5032a that came in under po 848361.1 case = 1000 needles lot# 9322472 (same lot as the other 2 rejections).Reason: 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: 10705004
• Report Number: 1911916-2020-00962
• Device Sequence Number: 11031506
• 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: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2020

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: 10/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/20/2020
• 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