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

Catalog Number 305180

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2023

Event Type  malfunction  

Event Description

It was reported that excess epoxy was found inside the cap and adhered to the bd¿ blunt fill needle while preparing a cryo-protectant mix.The following information was provided by the initial reporter: "a laboratory staff member was preparing cryo-protectant mix and attached a bd blunt fill needle to a syringe containing saline.They removed the needle cap and a small white fragment fell from the cap onto the edge of the syringe.The needle and syringe were rejected for use.On close inspection of the needle, it was evident that the fragment had been attached to the side of base of the needle as there were still some remains of the fragment on there.It also appears to be made up of the same glue or material that is used to adhere the needle to the base.Though these needle are not used directly on patients, they are used in the making of cryo-protectant mix.This is added to stem cells for cryopreservation which is subsequently infused into patients.Having discovered this there were two main concerns: a fragment ends up in the cryo-protectant mix and is infused in the patient.We use a filter during infusion so this risk is minimal; the fragment dissolves in the cryo-protectant mix and we are not aware if there is any adverse effect to patient if infused.".

Manufacturer Narrative

Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD¿ BLUNT FILL NEEDLE
• Type of Device: 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 ; 8448235433
• MDR Report Key: 16683022
• MDR Text Key: 312718144
• Report Number: 1911916-2023-00205
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 00382903051809
• UDI-Public: 00382903051809
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 305180
• Device Lot Number: 0115088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1