MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ BLUNT FILL NEEDLE; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305181
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coring occurred when the bd¿ blunt fill needle was used to draw up propofol from the vial.The following information was provided by the initial reporter: "nurse experienced coring with our blunt fill needle when drawing up propofol.Multiple incidents have occurred - all with propofol.".
Additional Manufacturer Narrative
Investigation summary - to aid in the investigation, six photos were provided for evaluation by our quality team.Two photos show a packaging blister top web.The other photos show the top part of a vial, the vial and a syringe with a needle assembly connected to it.No other information could be obtained from the photos.A device history record review was completed for provided material number 305181, lot number 2228065.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed, and without the physical sample analysis a probable root cause could not be offered.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.

• Brand Name: BD¿ BLUNT FILL NEEDLE
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16401953
• Report Number: 1911916-2023-00083
• Device Sequence Number: 3327680
• Product Code: GAA
• UDI-Device Identifier: 00382903051816
• UDI-Public: 00382903051816
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/30/2023

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: Health Professional
• Device Catalogue Number: 305181
• Device Lot Number: 2228065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown