MAUDE Adverse Event Report: BD CARIBE LTD. BD WHITACRE¿ SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405138

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/14/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd whitacre¿ spinal needle was found "sheared off" when removing it from the epidural ligament.As a result, the patient's cardiac surgery was postponed, and general anesthesia was needed to extract the broken needle piece.The following information was provided by the initial reporter: "attempted spinal procedure with 27g whitacre.The needle was passed through the 20g introducer and advanced into the epidural ligament.No csf endpoint was obtained.The introducer was replaced and spinal needle advanced to the hub and there still was no csf.The needle was then withdrawn.After withdrawing the needle was found to be sheared off.The patient's cardiac surgery was postponed.The patient required general anesthesia for extraction of the needle.The patient later had cardiac surgery.There were no long term adverse patient impact.Becton dickinson canada inc yes / oui canadian hospital specialties ltd (b)(6) 2022, pending assignment no / non a0401 - break / bris; e2403 - no clinical signs symptoms or conditions / aucun signe, symptôme ou condition cliniques; f19 - surgical intervention / intervention chirurgicale; f1909 - surgical procedure delayed / procédure chirurgicale retardée.

Event Description

It was reported that the bd whitacre¿ spinal needle was found "sheared off" when removing it from the epidural ligament.As a result, the patient's cardiac surgery was postponed, and general anesthesia was needed to extract the broken needle piece.The following information was provided by the initial reporter: "attempted spinal procedure with 27g whitacre.The needle was passed through the 20g introducer and advanced into the epidural ligament.No csf endpoint was obtained.The introducer was replaced and spinal needle advanced to the hub and there still was no csf.The needle was then withdrawn.After withdrawing the needle was found to be sheared off.The patient's cardiac surgery was postponed.The patient required general anesthesia for extraction of the needle.The patient later had cardiac surgery.There were no long term adverse patient impact.Becton dickinson canada inc yes / (b)(6) hospital specialties ltd (b)(6) 2022; pending assignment no / non a0401 - break / bris; e2403 - no clinical signs symptoms or conditions / aucun signe, symptôme ou condition cliniques; f19 - surgical intervention / intervention chirurgicale; f1909 - surgical procedure delayed / procédure chirurgicale retardée.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the mdr 2618282-2022-00102 is a duplicate of 2618282-2022-00095 this supplemental is to cancel mdr 2618282-2022-00102.

• Brand Name: BD WHITACRE¿ SPINAL NEEDLE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16091562
• MDR Text Key: 306586225
• Report Number: 2618282-2022-00102
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 00382904051389
• UDI-Public: 00382904051389
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/12/2023

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 Catalogue Number: 405138
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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