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

Catalog Number	405138
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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introducer was replaced and spinal needle advanced to the hub and there still was no csf.The needle was then withdrawn.After withdrawing the needle was found to be sheared off.The patient's cardiac surgery was postponed.The patient required general anesthesia for extraction of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 or Problem 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introducer was replaced and spinal needle advanced to the hub and there still was no csf.The needle was then withdrawn.After withdrawing the needle was found to be sheared off.The patient's cardiac surgery was postponed.The patient required general anesthesia for extraction of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.
Additional 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
• Common Device Name: 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
• Report Number: 2618282-2022-00102
• Device Sequence Number: 2044590
• Product Code: BSP
• UDI-Device Identifier: 00382904051389
• UDI-Public: 00382904051389
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 405138
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown