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

Catalog Number	305181
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: it was reported the needles are causing coring when drawing up propofol.To aid in the investigation, four photos were provided for evaluation by our quality team.Three photos show a vial with a dark colored speck.The other photo shows a packaging blister top web.From the photos it is not possible to confirm any potential defect of the needle.A device history record review was completed for provided material number 305181, lot 2228065.The review did not reveal any detected quality issues during the production of this lot that could have contributed to reported defect.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed, and without a 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.
Event or Problem Description
It was reported that the bd¿ blunt fill needle with syringe caused coring to occur in the medication vial while drawing up propofol.This occurred with 2 needles.The following information was provided by the initial reporter: "we received our new bd needles and i swapped them out on (b)(6) 2023.Coring with new needles from bd.They stated this only happens with propofol.It occurs because of how the stopper is manufactured and does not occur with other medications that they draw up with these blunt fill needles.One of the crna¿s reported that this happened at least 1 other time this morning, possibly more.The cores are small and propofol easily conceals the core if you are not looking for it.They also stated this happens anywhere these large bore metal needles are in use.One of them tried using a filter needle to draw up propofol.The filter needle still created a core which remained in the vial because the filter needle prevented it from moving into the syringe, but this would be a very inefficient way to draw up propofol.".

• Brand Name: BD¿ BLUNT FILL NEEDLE WITH SYRINGE
• 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: 16317093
• Report Number: 1911916-2023-00057
• Device Sequence Number: 20831262
• 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): 01/20/2023

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: 01/17/2023
• Initial Report FDA Received Date: 02/07/2023
• 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