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

Catalog Number 408381

Device Problem Break (1069)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device evaluated by mfr: 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 a needle break occurred with a spinal needle 27ga 3-1/2in.The following information was provided by the initial reporter, "during puncture for spinal anesthesia, the needle broke within the patient's rachidial space.Surgery was required for its removal.There was a need for surgical intervention.No permanent injuries.Surgical wound in paramedian lumbar region on the right, resection of posterior vertebral element and decompressive laminectomy.".

Manufacturer Narrative

H.6.Investigation: bd was provided with photos and samples for catalog 408381 lot 8331877 to investigate for this record.Samples were evaluated a shows a cannula/hub component bent near the detached piece of cannula.Style/handle component does not show breakage.As a result, bd was able to verify the reported issue.Due to the bent area at the cannula near the breakage, it seems likely that the breakage occurs during rectification.A potential root cause can be directed to handling issues based on the evaluation of the sample received.In addition, it seems likely that the repeated repositioning and the lack of introducer cause the needle to bend.Device history record review for the lots assessed does not show discrepancies related to broken cannula.All the inspections were performed as established per procedures with satisfactory results.

Event Description

It was reported that a needle break occurred with a spinal needle 27ga 3-1/2in.The following information was provided by the initial reporter, "during puncture for spinal anesthesia, the needle broke within the patient's rachidial space.Surgery was required for its removal.There was a need for surgical intervention.No permanent injuries.Surgical wound in paramedian lumbar region on the right, resection of posterior vertebral element and decompressive laminectomy.".

• 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: 8683848
• MDR Text Key: 147497422
• Report Number: 9610048-2019-00201
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 07891463003492
• UDI-Public: 7891463003492
• 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: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 408381
• Device Lot Number: 8331877
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention