MAUDE Adverse Event Report: BD CARIBE LTD. BD® QUINCKE SPINAL NEEDLES; ANESTHESIA CONDUCTION NEEDLE

Model Number 405181

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/09/2021

Event Type  malfunction  

Event Description

It was reported that the bd® quincke spinal needles had foreign matter on the bevel side of the needle.The following information was provided by the initial reporter: there is a marking on the bevel side of the spinal needle.The physician feels the product is compromised.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd® quincke spinal needles had foreign matter on the bevel side of the needle.The following information was provided by the initial reporter: there is a marking on the bevel side of the spinal needle.The physician feels the product is compromised.

Manufacturer Narrative

H6: investigation summary: there was no sample available but 2 photos were provided to bd for evaluation.Upon evaluation of the 2 photos, bd was able to confirm the reported issue.A review of the device history record was performed and no quality issues were found during production.A root cause could not be determined.

• Brand Name: BD® QUINCKE SPINAL NEEDLES
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12963661
• MDR Text Key: 284838003
• Report Number: 2618282-2021-00074
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904051816
• UDI-Public: 30382904051816
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

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 Model Number: 405181
• Device Catalogue Number: 405181
• Device Lot Number: 1236170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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