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

Model Number	405079
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/02/2022
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 that the needle broke off of the bd¿ spinal needle whitacre style.The patient required surgical removal of the embedded portion of the device.The following information was provided by the initial reporter, translated from spanish: when using the anesthesia needle, at the moment of puncturing the patient, it broke inside her, which has made the physician to open the patient (surgical intervention) to remove the needle fragment.I insert the needle, and at the moment when it collides, when the needle returns, this entire part comes out and the other fragment of the needle remains in the process.Automatically a piece comes to me and the other stays inside.When that happens, i make an incision of 1 cm more or less and with tweezers i manage to grab the tip and remove the rest of the needle that is inside the patient.What is the current status of the patient? the patient is currently well, she has not presented immediate consequences to the event presented, there are no signs of infection, bruising or neurological deficit currently.Was there any long-term consequence or harm due to the needle breaking, or due to surgery for removal? as a consequence, it presents a scar of approximately 2 linear cm in the skin, lumbar region.In good healing process.Secondary to the procedure for needle removal.
Additional Manufacturer Narrative
H.6.Investigation summary: based on the photo sample provided to bd for evaluation, cannula broken was confirmed through the photo provided as evidence for this investigation.Due to bent area at the cannula near the breakage, it seems likely that the breakage occurs during rectification.A potential root cause can be directed to possible handling issues with notable bends on the cannula which are indicative of repositioning (with a note in the ifu stating "repeated repositioning my increase the risk of needle breakage" and ¿remove spinal needle and introducer needle together¿.).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.
Event or Problem Description
It was reported that the needle broke off of the bd¿ spinal needle whitacre style.The patient required surgical removal of the embedded portion of the device.The following information was provided by the initial reporter, translated from spanish: when using the anesthesia needle, at the moment of puncturing the patient, it broke inside her, which has made the physician to open the patient (surgical intervention) to remove the needle fragment.I insert the needle, and at the moment when it collides, when the needle returns, this entire part comes out and the other fragment of the needle remains in the process.(.) automatically a piece comes to me and the other stays inside.When that happens, i make an incision of 1 cm more or less and with tweezers i manage to grab the tip and remove the rest of the needle that is inside the patient.What is the current status of the patient? a: the patient is currently well, she has not presented immediate consequences to the event presented, there are no signs of infection, bruising or neurological deficit currently.Was there any long-term consequence or harm due to the needle breaking, or due to surgery for removal? a: as a consequence, it presents a scar of approximately 2 linear cm in the skin, lumbar region.In good healing process.Secondary to the procedure for needle removal.

• Brand Name: BD¿ SPINAL NEEDLE WHITACRE STYLE
• 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: 15294891
• Report Number: 2618282-2022-00049
• Device Sequence Number: 6276929
• Product Code: BSP
• UDI-Device Identifier: 30382904050796
• UDI-Public: 30382904050796
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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: 07/31/2026
• Device Model Number: 405079
• Device Catalogue Number: 405079
• Device Lot Number: 1215802
• 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: 08/02/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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 Sex: Unknown