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

Catalog Number	405138
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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introducer was replaced, and spinal needle advanced to the hub and there still was no csf.The needle was then withdrawn.After withdrawing the needle was found to be sheared off.
Additional 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 or Problem 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introducer was replaced, and spinal needle advanced to the hub and there still was no csf.The needle was then withdrawn.After withdrawing the needle was found to be sheared off.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
• 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: 16017720
• Report Number: 2618282-2022-00095
• Device Sequence Number: 5620348
• Product Code: BSP
• UDI-Device Identifier: 00382904051389
• UDI-Public: 00382904051389
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K210978
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• 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: 12/01/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/30/2023
• 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
• Patient Sex: Unknown