MAUDE Adverse Event Report: COOK INC COOK SPECTRUM; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	G43981
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray (b)(4).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 cook spectrum minocycline/rifampin impregnated double lumen central venous catheter was leaking.As reported, it is unknown how long the device was in use or where the leak was located.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Additional information from the doctor was received on 07/13/2018 reporting that the leakage was noted around the blue hub.He described it as a crack in the hub though it was hard to see this through the biohazard bag.All 3 catheters were placed in the same day, and two of the complaint devices were placed in one patient.The physician stated that he noticed the leak when blood was backing up around the hub.The third line was placed by a different operator in the icu but with the same issue on the same day.It was stated that the hospital has been using the same pre assembled 4 way stop cock from another manufacturer with this device for a decade and have not ever had this occur.They attach the stop cock onto the second proximal or medial lumen.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Investigation - evaluation a review of the complaint history, drawings, documentation, manufacturing instructions, quality control and instructions for use (ifu) were conducted during the investigation.The reported used device was returned for evaluation.Visual inspection observed the presence of biomatter, slight discoloration, wear marking on the blue hub and a crack in the blue hub.Leak testing was completed and verified the reported issue.The device was seen to leak where the blue hub connects to the needleless connector at the location of the crack.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Incoming quality control (qc) ensures inspection of the hub/luer fittings and the devices are 100% leak tested during final qc.The proper procedures are in place to identify/prevent this failure mode prior to device distribution.A review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number aside from its associated complain reported on medwatch 1820334-2018-01904.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
See h10.

• Brand Name: COOK SPECTRUM
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7660124
• Report Number: 1820334-2018-01905
• Device Sequence Number: 176551
• Product Code: FOZ
• UDI-Device Identifier: 00827002439818
• UDI-Public: (01)00827002439818(17)200321(10)8773047
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K033843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2018

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: 03/21/2020
• Device Model Number: G43981
• Device Catalogue Number: C-UDLMY-501J-ABRM-HC-FST
• Device Lot Number: 8773047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 07/13/2018; 09/19/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 08/08/2018; 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1