MAUDE Adverse Event Report: CAREFUSION, INC EPIDURAL TRAY PERISAFE¿ CONTINUOUS TUOHY 18 GAUGE 3-1/2 INCH; ANESTHESIA CONDUCTION KIT

Catalog Number	406047
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Pma/510(k)#: enforcement discretion.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
Material no.: 406047 batch no.: 0001310661.It was reported that during use of the epidural tray perisafe¿ continuous tuohy 18 gauge 3-1/2 inch the needle from the catheter broke off inside the patient and could not be retrieved.The following information was provided by the initial reporter: we had another incident with one of the epidural trays.This time the catheter needle broke off inside the patient and they were not able to retrieve it.This came from with lot # 0001310661 and ref (b)(4).
Event or Problem Description
Material no.: 406047.Batch no.: 0001310661.It was reported that during use of the epidural tray perisafe¿ continuous tuohy 18 gauge 3-1/2 inch the needle from the catheter broke off inside the patient and could not be retrieved.The following information was provided by the initial reporter: we had another incident with one of the epidural trays.This time the catheter needle broke off inside the patient and they were not able to retrieve it.This came from with lot # 0001310661 and ref 406047.
Additional Manufacturer Narrative
Investigation summary: no photos or samples were returned for evaluation, therefore failure mode could not be verified and root cause could not be determined.Based on the limited results of the complaint investigation, a probable root cause could not be identified since no complaint sample was submitted for evaluation and no contributions from the manufacturing/design process were identified.Since no probable root cause was identified, the investigation was not able to identify any corrective or preventive actions.This complaint will be entered into the complaint management system and will be tracked and trended through the quality data analysis process for future occurrences.A device history record review of all applicable manufacturing records for lot 0001310661 did not identify any issues that may have contributed to the reported failure mode.

• Brand Name: EPIDURAL TRAY PERISAFE¿ CONTINUOUS TUOHY 18 GAUGE 3-1/2 INCH
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 9233684
• Report Number: 1625685-2019-00120
• Device Sequence Number: 2233410
• Product Code: CAZ
• UDI-Device Identifier: 00382904060473
• UDI-Public: 00382904060473
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• 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): 12/19/2019

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: 09/30/2020
• Device Catalogue Number: 406047
• Device Lot Number: 0001310661
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other