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	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while using bd whitacre high flow pencil point spinal needles, sterile, single use the needle broke during use.The following information was provided by the initial reporter: needle broke off in patient, ct scan and incision required for removal.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 19-oct-2022.H6: investigation summary one sample was provided to our quality team for investigation.Through visual inspection, the needle was observed to be broken.It was noted the stylet was bent, indicating it was repositioned.A review of the device history record was performed for reported lot 8123892 and no quality issues were found during production that could have contributed to this incident.Based on the sample evaluation, it was determined this incident was likely caused due to repositioning the needle during use, this action can lead to needle breakage.
Event or Problem Description
It was reported while using bd whitacre high flow pencil point spinal needles, sterile, single use the needle broke during use.The following information was provided by the initial reporter: needle broke off in patient, ct scan and incision required for removal.

• 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: 15696053
• Report Number: 2618282-2022-00069
• Device Sequence Number: 15153819
• Product Code: BSP
• UDI-Device Identifier: 00382904051389
• UDI-Public: 00382904051389
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 405138
• Device Lot Number: 8123892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2018
• 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