MAUDE Adverse Event Report: BD UNIVIA¿ WHITACRE SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405075

Device Problem Complete Blockage (1094)

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

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.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 univia¿ whitacre spinal needle was blocked during the puncture.The following information was provided by the initial reporter, translated from (b)(6) to english: "no liquor came out and the needle was bent, the patient was pricked again.If the puncture was really unsuccessful, the patient would have to be put under anesthesia.Certainly not a desirable situation.It turns out that during spinal puncture, liquor doesn't always come back so you can't be sure if you're right on it.".

Event Description

It was reported that the bd univia¿ whitacre spinal needle was blocked during the puncture.The following information was provided by the initial reporter, translated from dutch to english: "no liquor came out and the needle was bent, the patient was pricked again.If the puncture was really unsuccessful, the patient would have to be put under anesthesia.Certainly not a desirable situation.It turns out that during spinal puncture, liquor doesn't always come back so you can't be sure if you're right on it.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for evaluation?: yes.D.10.Returned to manufacturer on: 8/3/2021.H.6.Investigation: one sample was provided to our quality engineer team for investigation.Upon visual inspection of the product, it was observed the needle and stylet was completely bent, however, the introducer showed no damage or defect.A device history review was performed for reported lot 2103020, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Because the introducer needle is not attached to the cannula with this product, there is an increased chance of the needle becoming bent.The assembly of the introducer needle to the cannula is a manual process and personnel are trained specifically for this function due to the care required while performing.Given the condition of the introducer, if the needle was bent during manufacturing, proper assembly would not have been possible.Product undergoes visual inspections throughout the manufacturing process, verifying no defects or damage is present on the needle or any other components.Based on our quality team's investigation and the sample evaluation, it appears the needle bent during use, preventing the liquid from flowing.

• Brand Name: BD UNIVIA¿ WHITACRE SPINAL NEEDLE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• MDR Report Key: 12256250
• MDR Text Key: 264511295
• Report Number: 3003152976-2021-00440
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405075
• Device Lot Number: 2103020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Date Manufacturer Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• 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