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

Catalog Number 400370

Device Problem Contamination (1120)

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

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 while using the bd quincke spinal needle had foreign matter.The following was received from the initial reporter: today we used bd spinal needle for the application of barrigel to the space between rectum and prostate.Priming the needle with barrigel we found some residual metallic coloured substance on gauze.

Manufacturer Narrative

H6: investigation summary: three photos received by our quality team for investigation.Through visual inspection, in the first photo it is observed a needle on a white napkin, residues of some kind of gel and a smear on the napkin.In the second photo several needles are seen with residue of blood as some kind of gel, also small smears are observed, and the third photo shows the tyvek with the catalog¿s data.A device history review was performed for lot 3041718, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.

Event Description

It was reported that while using the bd quincke spinal needle had foreign matter.The following was received from the initial reporter: today we used bd spinal needle for the application of barrigel to the space between rectum and prostate.Priming the needle with barrigel we found some residual metallic coloured substance on gauze.

• 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 IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17845957
• MDR Text Key: 324619999
• Report Number: 2618282-2023-00074
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 10/10/2023

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: 400370
• Device Lot Number: 3041718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 09/29/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• 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