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

Model Number	409442
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
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 that the bd whitacre¿ spinal needle hub was damaged.The following information was provided by the initial reporter, translated from spanish: "material defective".
Event or Problem Description
It was reported that the bd whitacre¿ spinal needle hub experienced a broken needle.The following information was provided by the initial reporter, translated from spanish: material defective.At the beginning of the procedure, the nurse opened the needle and when the anesthesiologist took it, he realized that a piece was missing from needle, the nurse immediately provided another, it did not affect anything that started the surgery, much less the patient, when the nurse returned, the needle was checked for the rest and they were complete, it was only one needle that came out with that defect.That was what happened.- quantity affected; only one.- was incident noticed prior, during or after use? before patient use.- was there any damage/impact to patient/health professional? no.- was medical intervention needed? no.
Additional Manufacturer Narrative
H.6.Investigation summary: one (1) photo was provided by the customer for this investigation.It is observed a needle with a shield, no stylet is seen.No actual sample was provided.Bd was able to confirm the customer¿s indicated failure mode with the photo provided.The most probable cause of missing stylet is related to transfer station in which the stylet is assembled to the cannula.The manufacturing facility has been notified of this incident and no discrepancy or non-conformance were identified that could have contributed to the reported condition.A review of the device history record was performed, and no quality issues were found during production.
Additional Manufacturer Narrative
B.5 event desc: it was reported that the bd whitacre¿ spinal needle hub experienced a broken needle.The following information was provided by the initial reporter, translated from spanish: material defective.At the beginning of the procedure, the nurse opened the needle and when the anesthesiologist took it, he realized that a piece was missing from needle, the nurse immediately provided another, it did not affect anything that started the surgery, much less the patient, when the nurse returned, the needle was checked for the rest and they were complete, it was only one needle that came out with that defect.That was what happened.- quantity affected; only one.- was incident noticed prior, during or after use? before patient use.- was there any damage/impact to patient/health professional? no.- was medical intervention needed? no.H.3 imdrf annex a code: a0413 - material separation.
Event or Problem Description
It was reported that the bd whitacre¿ spinal needle hub experienced a broken needle.The following information was provided by the initial reporter, translated from spanish: material defective.At the beginning of the procedure, the nurse opened the needle and when the anesthesiologist took it, he realized that a piece was missing from needle, the nurse immediately provided another, it did not affect anything that started the surgery, much less the patient, when the nurse returned, the needle was checked for the rest and they were complete, it was only one needle that came out with that defect.That was what happened.- quantity affected; only one.- was incident noticed prior, during or after use? before patient use.- was there any damage/impact to patient/health professional? no.- was medical intervention needed? no.

• 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: 15182954
• Report Number: 2618282-2022-00040
• Device Sequence Number: 5809205
• Product Code: BSP
• UDI-Device Identifier: 30382904094424
• UDI-Public: 30382904094424
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2022

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 Expiration Date: 08/31/2026
• Device Model Number: 409442
• Device Catalogue Number: 409442
• Device Lot Number: 1259736
• 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: 07/12/2022
• Supplement Date Received by Manufacturer: 08/15/2022; 09/11/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/06/2022; 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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
• Patient Sex: Unknown