MAUDE Adverse Event Report: COOK INC COOK TPN SINGLE LUMEN CATHETER REPAIR SET; DQY CATHETER, PERCUTANEOUS

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: not exempt, pre-amendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of the investigation.

Event Description

The customer reported the following general complaints.These issues occurred during administration of total parenteral nutrition (tpn): the redo single lumen tpn catheters sometimes become loose or spin where the hard plastic goes into the silicone.These events are captured in mfr.Report # 1820334-2019-01311 and mfr.Report # 1820334-2019-01313.While attempting to repair the redo single lumen tpn catheters, it is sometimes found that the repair kits are also loose or spin where the hard plastic goes into the silicone.This problem is discovered with the repair kits before patient contact.The procedures are completed with repair kits of the same type that do not have this problem.This report captures one event with a 4fr device.The other event with a 3fr device is referenced in mfr.Report # 1820334-2019-01314.As reported, these occurrences have not caused or contributed to any adverse effects to the patients.Additional event details have been requested.At the time of this report, this is the only information available.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation.A review of the complaint history, instructions for use, quality control, specifications and trends of the device was conducted during the investigation.The complaint device was not returned.Therefore, a physical investigation of the returned complaint device could not be completed.A document based investigation evaluation was performed, and it was concluded that the device aspect in question was visually and functionally inspected by quality control.No related gaps in production or processing controls were noted.The risk specification for this product includes the loss of use failure mode and identifies the risk controls that are in place to mitigate the risk of this type of failure.A review of the device history record could not be conducted, as the lot information is unknown.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, no returned product and the results of the investigation, a definitive cause could not be established.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor 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 Description

No new event description information to report at this time.

• Brand Name: COOK TPN SINGLE LUMEN CATHETER REPAIR SET
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8655538
• MDR Text Key: 146649091
• Report Number: 1820334-2019-01312
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-RHCS-4.0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1