MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD WHITACRE쳌쳌¿ NEEDLE 27G X 3.5 IN.; SPINAL NEEDLE

Catalog Number 408394

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 01/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that during use of the bd whitacre쳌쳌¿ needle spinal anesthesia with 1 attempt of puncture and without resistance.At the end of the procedure the anesthesiologist realizes that the part of the needle was retained at the puncture site.The packaging was intact and it was not identified change in the integrity of the material before opening the packaging.Surgical procedure was performed to remove the needle.

Manufacturer Narrative

Investigation summary: bd was able to verify the reported issue per the returned device.The device was received from cavity two and was observed a bend on detach part of the cannula.It seems likely that the breakage occurs during rectification.It is explained in the ifu that this practice may increase needle breakage.Potential root cause can be directed to possible handling issues based on the evaluation of the sample received.It seems likely that the breakage occurs due to repeated repositioning.As it is explained in the ifu, this practice may increase the risk of needle breakage and therefore it is not recommended.It seems likely that the repeated repositioning also caused the needle to bend.The manufacturing records were reviewed for the incident lots and no discrepancy or related non-conformance were identified that could have contributed to the reported condition.No incidents related to broken needle were reported during in-process or final inspections.

Event Description

It was reported that during use of the bd whitacre쳌쳌¿ needle spinal anesthesia with 1 attempt of puncture and without resistance.At the end of the procedure the anesthesiologist realizes that the part of the needle was retained at the puncture site.The packaging was intact and it was not identified change in the integrity of the material before opening the packaging.Surgical procedure was performed to remove the needle.

• Brand Name: BD WHITACRE쳌쳌¿ NEEDLE 27G X 3.5 IN.
• 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: 8337557
• MDR Text Key: 136109996
• Report Number: 9610048-2019-00113
• 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: 03/01/2019

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: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 408394
• Device Lot Number: 8004885
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention