MAUDE Adverse Event Report: COOK INC REDO SINGLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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

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.This report captures one event for the 3fr device, while a second event for the 4fr device is addressed in mfr.Report # 1820334-2019-01311.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.These events are captured in mfr.Report # 1820334-2019-01312 and 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 (ifu), quality control documents, specifications of the device, and complaint trends were conducted during the investigation.The visual inspection of the complaint device was not possible, as the device was not returned to aid in the investigation.A document based investigation evaluation was performed.The device master record (dmr) review revealed that appropriate controls are in place to address the reported failure mode and sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) and a search for similar complaints from the same lot could not be completed because lot information was not available.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.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 inspection of returned product, and the results of the investigation, a definitive cause could not be established.It is feasible to suggest that the shipping and handling of the complaint device could have contributed to this failure mode.Per the quality engineering risk assessment no further action is required.The appropriate personnel have been notified and 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 additional information regarding the patient or event has been received.

• Brand Name: REDO SINGLE LUMEN TPN CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8655568
• MDR Text Key: 146648950
• Report Number: 1820334-2019-01313
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K950118
• 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: 07/18/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-3.0-65-REDO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1