MAUDE Adverse Event Report: TRAY SPN WHIT27G3.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Model Number	405699
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the tray spn whit27g3.5 l/b-d/e needle broke off in the patient's back during use.As a result, the patient will be receiving a surgery consultation for removal of the needle under fluoroscopy.The following information was provided by the initial reporter: "the dr.Reports that the needle broke inside the patient's body." "during a spinal anesthesia attempt as usual.Needle broke, leaving about 1 1/2 inch inside patients back when i retrieved without resistance.Is the first time in 20 years that happen to me.I believe needle.Had some issue or are broken." "need surgery consult for open removal of needle tip under fluoroscopy".
Event or Problem Description
It was reported that the tray spn whit27g3.5 l/b-d/e needle broke off in the patient's back during use.As a result, the patient will be receiving a surgery consultation for removal of the needle under fluoroscopy.The following information was provided by the initial reporter: "the dr.Reports that the needle broke inside the patient's body." "during a spinal anesthesia attempt as usual.Needle broke, leaving about 1 1/2 inch inside patients back when i retrieved without resistance.Is the first time in 20 years that happen to me.I believe needle.Had some issue or are broken." "need surgery consult for open removal of needle tip under fluoroscopy.".
Additional Manufacturer Narrative
H6: investigation summary: no sample was returned for analysis.Consequently, the investigation was not able to further evaluate the reported failure mode through a complaint sample analysis.Without a sample or photograph the investigation was unable to confirm the failure mode nor identify a probable root cause.As the failure mode was unable to be confirmed nor a root cause able to be determined a corrective and/or preventive action could not be identified for this complaint.This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences.A device history review was conducted for the following possible lot numbers: three possible lots were provided.A review of the device history record noted no issues relating to the reported failure mode for lot # 0001337953.A review of the device history record noted no issues relating to the reported failure mode for lot # 0001362141.A review of the device history record was not possible for lot # 000130379 which could not be confirmed and does not exist.

• Brand Name: TRAY SPN WHIT27G3.5 L/B-D/E
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10496064
• Report Number: 1625685-2020-00082
• Device Sequence Number: 2939065
• Product Code: CAZ
• UDI-Device Identifier: 00382904056995
• UDI-Public: 00382904056995
• Combination Product (Y/N): N
• PMA/510(K) Number: DISCRETION
• Number of Events Summarized: 1
• Summary Report (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): 02/03/2021

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 Model Number: 405699
• Device Catalogue Number: 405699
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 02/03/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention