MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD WHITACRE¿ NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 408394

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 bd whitacre¿ needle broke off into the patient during use.A tomography was used to identify the location of the needle fragment, and a separate procedure was needed to remove it.The following information was provided by the initial reporter, translated from (b)(6) to english: "when introducing the needle into the patient, the anesthesiologist felt a snap and when pulling it came the part of the needle and the bevel came out whole without bending.The tomography identified the artifact between the l3-l4 space, with depth to the epidural fat, not perforating the dura mater and not invading the spinal canal.The patient needed another procedure to remove the needle fragment.".

Event Description

It was reported that the bd whitacre¿ needle broke off into the patient during use.A tomography was used to identify the location of the needle fragment, and a separate procedure was needed to remove it.The following information was provided by the initial reporter, translated from portuguese to english: "when introducing the needle into the patient, the anesthesiologist felt a snap and when pulling it came the part of the needle and the bevel came out whole without bending.The tomography identified the artifact between the l3-l4 space, with depth to the epidural fat, not perforating the dura mater and not invading the spinal canal.The patient needed another procedure to remove the needle fragment.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10/19/2021.H.6.Investigation: based on the sample provided to bd for evaluation, the reported condition was verified.The manufacturing facility has been notified of this incident and no discrepancy or non-conformance were identified that could have contributed to the reported condition.A review of the device history record was performed, and no quality issues were found during production.According to the description of the complaint, the needle broke during use, there may have been a probable usability error may have occurred.H3 other text : see h.10.

• Brand Name: BD WHITACRE¿ NEEDLE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12502390
• MDR Text Key: 272427840
• Report Number: 9610048-2021-00129
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

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: 8010903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention