MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD¿ NEEDLE FOR SPINAL ANESTHESIA SPINAL 27GX3 - 1/2; SPINAL NEEDLE

Catalog Number 408381

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd¿ needle for spinal anesthesia spinal 27gx3 - 1/2 broke during withdrawal, the patient ¿had a frontal displacement and the needle broke¿.A piece of the needle remained in the patient.Furthermore, the patient received surgery in order to remove the needle.

Event Description

It was reported that bd needle for spinal anesthesia spinal 27gx3 - 1/2 broke during withdrawal, the patient ¿had a frontal displacement and the needle broke¿.A piece of the needle remained in the patient.Furthermore, the patient received surgery in order to remove the needle.

Manufacturer Narrative

A review of the device history record was completed for the bd juncos 405155, lots 7013875 and 7044833 used on (b)(4), lot 8038713.The sub-assembly material number: (b)(4), spinal needle 27 x 3 1/2in quincke- bulk.No pictures or samples included in the complaint record.Bd juncos was not able to confirm that the customer¿s indicated failure mode is associated with the manufacturing processes.

• Brand Name: BD¿ NEEDLE FOR SPINAL ANESTHESIA SPINAL 27GX3 - 1/2
• 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: 7934594
• MDR Text Key: 122793911
• Report Number: 9610048-2018-00145
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

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: 01/31/2023
• Device Catalogue Number: 408381
• Device Lot Number: 8038713
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/04/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR