MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SPINAL NEEDLE 22GA 3.50 IN; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405256

Device Problem Packaging Problem (3007)

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

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: one sample was provided to our quality team for investigation.Upon visual inspection, the needle was observed to be bent; therefore the reported failure could be verified.It was noted there was a perforation in the packaging at the same location where the needle was bent.A device history review was performed for reported lot 2002008, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of the same lot were also used for additional evaluation.All product was visually inspected, no damage or defects were observed on any of the needles.Product is inspected throughout the manufacturing process according to procedure, verifying all critical dimensions are within specification and there is no damage or defects with the product.All records were reviewed and no issues were identified during inspections for the reported lot.While we cannot identify a direct issue, based on the sample evaluation it was determined this incident is related to a jam within the packaging machine, personnel not properly identifying the damaged product during their inspections.Manufacturing personnel have been notified of this incident to increase awareness during inspections.Complaints received for this device and reported issue will continue to be tracked and trended for future occurrence.

Event Description

It was reported that the spinal needle 22ga 3.50 in packaging had a tear in it, compromising the product's sterility.The following information was provided by the initial reporter, translated from french to english: "the needle bent at the level of the hub." via bd investigation: "it can be observed that the packaging film has a perforation right in the same place where the needle starts to bend.".

• Brand Name: SPINAL NEEDLE 22GA 3.50 IN
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12238612
• MDR Text Key: 264843538
• Report Number: 3003152976-2021-00427
• 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,health professional,o
• Type of Report: Initial
• Report Date: 07/26/2021

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: Other
• Device Catalogue Number: 405256
• Device Lot Number: 2002008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2020
• 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