MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE VENTED NOKOR 16X1 TW; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number	305213
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: a device history record review could not be completed for this complaint as the lot number provided is 'unknown.' to aid in the investigation, five samples were received for evaluation by our quality team.A visual inspection was performed.The samples came with the plastic shield and all have plastic flash at the bottom of the needle hub.It could be possible for this defect to occur during the stop/start of the molding process.Based on the investigation with the returned sample analysis the symptom reported by the customer is confirmed.Further action has not been determined necessary at this time.
Event or Problem Description
It was reported that a needle vented nokor 16x1 tw had molding defects with sharp protrusions before use.The following was reported by the initial reporter: "it was reported that product received with flashing.Per attached email: we receive a shipment for item # 305213 (busse # 5032a) with flashing.I believe this is the third time we have receive this item with the same issue.We would like this return.Please see if you can provide a rga number for this.".

• Brand Name: NEEDLE VENTED NOKOR 16X1 TW
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11572514
• Report Number: 2243072-2021-00878
• Device Sequence Number: 17049428
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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 Model Number: 305213
• Device Catalogue Number: 305213
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1