MAUDE Adverse Event Report: CARDINAL HEALTH D.R. 203 II LTD TIBURON LAPAROSCOPY PACK, 10/CS; GENERAL SURGERY TRAY (KIT)

Catalog Number	29242
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There were no known adverse effects to the patient; however due to the patient¿s age and increased general anesthesia time, cardinal health is proactively filing this complaint.Based on the product number and lot number provided, the device history record was reviewed and no quality issues were reported.The inspections records were also verified and no issues were found related to the reported issue.All devices are made with qualified, tested and approved materials.All operators are certified in their operations and in compliance with applicable standard production method (spm).The sample was received and evaluated and it was confirmed that the stain on the btc (back table cover) was caused by a defective hot melt nozzle that generated a glue spot between the non-woven and the film of the btc.The corrective action was to re-train the laminator operator and the maintenance technician in the verification and cleaning process of the hot melt nozzle.  we will continue to monitor complaints for any trends of this nature.
Event or Problem Description
When opening for the case, the scrub nurse noted a stain on the back table cover.Instrumentation for the case had already been placed on the back table so it required a new set-up for the case causing a delayed start to the procedure.The (b)(6) year old patient was in the process of being induced so the incident did extend the length of general anesthesia exposure.The case was a hysteroscopy and d&c.

• Brand Name: TIBURON LAPAROSCOPY PACK, 10/CS
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): CARDINAL HEALTH D.R. 203 II LTD; zona franca las americas km22,; santo domingo ; DR
• MDR Report Key: 6616131
• Report Number: 1423537-2017-00100
• Device Sequence Number: 13631527
• Product Code: LRO
• UDI-Device Identifier: 50885380071551
• UDI-Public: 50885380071551
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/06/2017

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?: No
• Operator of Device: Nurse
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 29242
• Device Lot Number: 17BQR009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 06/06/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Weight: 83