MAUDE Adverse Event Report: BD CARIBE LTD. BD WHITACRE HIGH FLOW PENCIL POINT SPINAL NEEDLES, STERILE, SINGLE USE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405138

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

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 the bd whitacre high flow pencil point spinal needles, sterile, single use was sheared off.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introducer was replaced, and spinal needle advanced to the hub and there still was no csf.The needle was then withdrawn.After withdrawing the needle was found to be sheared off.

Manufacturer Narrative

H6: investigation summary no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed.  based on the available information we are not able to identify a root cause at this time.H3 other text : see h10.

Event Description

It was reported that the bd whitacre high flow pencil point spinal needles, sterile, single use was sheared off.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introducer was replaced, and spinal needle advanced to the hub and there still was no csf.The needle was then withdrawn.After withdrawing the needle was found to be sheared off.

• Brand Name: BD WHITACRE HIGH FLOW PENCIL POINT SPINAL NEEDLES, STERILE, SINGLE USE
• 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: 16017720
• MDR Text Key: 305839966
• Report Number: 2618282-2022-00095
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K210978
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 12/01/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/30/2023
• 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