MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. SPINAL NEEDLE 22GA 3-1/2IN

Catalog Number 408377

Device Problem Component Incompatible (1108)

Patient Problem No Information (3190)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 mandrel was found to be larger than the spinal needle 22 ga 3-1/2 in before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "mandrel is larger than the needle.".

Manufacturer Narrative

Investigation: our quality engineer was unable to verify the reported complaint.Photos or samples are not available for analysis and because no objective evidence of this issue was found during the analysis of the device history record and quality notifications for the claimed lot, it was not possible to verify this complaint as being generated by manufacturing process.

Event Description

It was reported that the mandrel was found to be larger than the spinal needle 22ga 3-1/2in before use.The following information was provided by the initial reporter, translated from portuguese to english: "mandrel is larger than the needle.".

• Brand Name: SPINAL NEEDLE 22GA 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: 8549667
• MDR Text Key: 147255803
• Report Number: 9610048-2019-00159
• 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,other
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 408377
• Device Lot Number: 8270618
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other