MAUDE Adverse Event Report: COOK INC PERICARDIOCENTESIS CATHETER TRAY; GBX CATHETER, IRRIGATION

Catalog Number	C-PCSY-830-AT
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: exempt.The complaint device has been returned and an evaluation will take place during the investigation.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a pericardiocentesis catheter tray chosen from the clean supply room was opened during paracentesis and was found to be covered with an unknown substance.The kit was removed from the procedure area and a like kit was used to complete the procedure.The reported kit did not make patient contact.As reported, the patient did not experience any adverse effects or require additional procedures due to this occurrence.
Additional Manufacturer Narrative
Inspection and analysis of the returned device was performed on 20dec2018.It was determined that one of the lidocaine vial included inside the kit had broken.The tray material and its contents appeared stained due to this liquid saturation.This incident was reassessed and determined not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or product malfunction that would cause or contribute to a serious injury or death.The broken lidocaine vial was easily detectable prior to use.

• Brand Name: PERICARDIOCENTESIS CATHETER TRAY
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8052695
• Report Number: 1820334-2018-03194
• Device Sequence Number: 1624896
• Product Code: GBX
• UDI-Device Identifier: 00827002052529
• UDI-Public: (01)00827002052529(17)200930(10)9020603
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: C-PCSY-830-AT
• Device Lot Number: 9020603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1