MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE VENTED NOKOR 18X1 TW; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number	305214
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter state: address information was not able to be obtained.(b)(6) was used as a place holder based on the user area code.(b)(4) investigation summary: approximately 1000 samples were received for evaluation (5 shelf boxes with 100 each and one plastic back with bulked packaging blisters).All the samples were in sealed packaging blisters.200 samples were randomly selected and were visually inspected with a 10x magnifier lens.No coring was observed, no other defect was observed.The symptom reported was not confirmed.Batch records show no issues were experienced while producing this batch.Samples received were found acceptable.Therefore, no further action is required.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: this is the 1st complaint for lot # 9162568 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: the symptom reported was not confirmed.Batch records show no issues were experienced while producing this batch.Samples received were found acceptable.Rationale: capa not required at this time.
Event or Problem Description
It was reported that the needles are coring prior to use with a bd needle vented nokor 18x1 tw.The following information was provided by the initial reporter: it was reported needles are coring.

• Brand Name: BD NEEDLE VENTED NOKOR 18X1 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: 10131438
• Report Number: 1911916-2020-00536
• Device Sequence Number: 2392706
• Product Code: GAA
• UDI-Device Identifier: 30382903052142
• UDI-Public: 30382903052142
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/22/2020

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: 07/31/2024
• Device Model Number: 305214
• Device Catalogue Number: 305214
• Device Lot Number: 9162568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/08/2020
• 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