MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. SPINAL NEEDLE 27GA 3-1/2IN

Catalog Number 408381

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

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 packaging on the spinal needle 27ga 3-1/2in was difficult to open before use and tore, leaving paper shards in the needle's sterile field.The following information was provided by the initial reporter, translated from (b)(6) to english: "we are still facing difficulty to open the spinal needle.Batch: 9115649.Additional information: the difficult to open the package was noticed before the use.There was no damage to patient/health professional.".

Manufacturer Narrative

H.6.Investigation: a physical sample was not available for investigation but bd was provided with a photo of the defect for evaluation.A review of the device history record was performed for the reported lot, 9115649, and no quality issues were found during production.Our quality engineer reviewed the provided photo and determined that the packaging was torn.Based off the provided photo the engineer was able to verify the reported issue.However, without a physical sample available for investigation a definitive root cause could not be determined.

Event Description

It was reported that the packaging on the spinal needle 27ga 3-1/2in was difficult to open before use and tore, leaving paper shards in the needle's sterile field.The following information was provided by the initial reporter, translated from portuguese to english: "we are still facing difficulty to open the spinal needle.Batch: 9115649.Additional information: the difficult to open the package was noticed before the use.There was no damage to patient/health professional.".

• Brand Name: SPINAL NEEDLE 27GA 3-1/2IN
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 9913362
• MDR Text Key: 202743034
• Report Number: 9610048-2020-00050
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 408381
• Device Lot Number: 9115649
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other