MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ SPINAL NEEDLE WHITACRE STYLE 27 GAUGE; ANESTHESIA CONDUCTION NEEDLE

Model Number	405079
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 while using bd¿ spinal needle whitacre style 27 gauge the needle broke off potentially in the patient.Two separate pieces broke.X rays and tomography were performed and nothing was found.The following information was provided by the initial reporter: at the time of trying to block the patient, the anesthesiologist comments that when removing the needle it broke, the anesthesiologist was left wondering if it really broke inside the patient; x-rays are performed on the patient in which no fragment of the needle can be seen.(b)(6) 2022, the anesthesiologist confirms that a tomography was performed on the patient, not finding any fragment of said needle, the patient is stable at the moment there are two pieces involved: one needle was the one that broke inside the patient and the other the anesthesiologist to check if it would suffer a break, manipulated it before using it, checking that it also broke.
Additional Manufacturer Narrative
Investigation summary: there was no sample available but 2 photos were provided to bd for evaluation.Upon evaluation of the photos, bd can confirm the reported issue.The most probably root cause is the repositioning of the needle as indicated by the bent portion of cannula near the breakage.A review of the device history record was performed and no quality issues were found during production.
Event or Problem Description
It was reported while using bd¿ spinal needle whitacre style 27 gauge the needle broke off potentially in the patient.Two separate pieces broke.X rays and tomography were performed and nothing was found.The following information was provided by the initial reporter: at the time of trying to block the patient, the anesthesiologist comments that when removing the needle it broke, the anesthesiologist was left wondering if it really broke inside the patient; x-rays are performed on the patient in which no fragment of the needle can be seen.(b)(6) 2022, the anesthesiologist confirms that a tomography was performed on the patient, not finding any fragment of said needle, the patient is stable at the moment there are two pieces involved: one needle was the one that broke inside the patient and the other the anesthesiologist to check if it would suffer a break, manipulated it before using it, checking that it also broke.

• Brand Name: BD¿ SPINAL NEEDLE WHITACRE STYLE 27 GAUGE
• 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: 13697969
• Report Number: 2618282-2022-00006
• Device Sequence Number: 12372096
• Product Code: BSP
• UDI-Device Identifier: 30382904050796
• UDI-Public: 30382904050796
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: 405079
• Device Catalogue Number: 405079
• Device Lot Number: 1145498
• 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: 02/23/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 70 KG