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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC REDO SINGLE LUMEN TPN CATHETER SET

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COOK INC REDO SINGLE LUMEN TPN CATHETER SET Back to Search Results
Catalog Number C-TPNS-3.0-65-REDO
Device Problems Fluid Leak (1250); Material Split, Cut or Torn (4008)
Patient Problem No Code Available (3191)
Event Date 11/25/2020
Event Type  malfunction  
Manufacturer Narrative
Common device name: not available as this device is not sold in the us, but it is considered to be clinically similar to a device that is, thus prompting this report. Pma/510(k): not available as this device is not sold in the us, but it is considered to be clinically similar to a device that is, thus prompting this report. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It was reported that a break was noticed in the line of a redo single lumen tpn catheter. The patient's father was flushing the picc line at home when he noticed saline spraying out from a break in the line. The line was cleaned, clamped, and covered before the patient and their father presented at the hospital. The line was originally implanted at bc children's hospital but the patient went to ach in calgary to treat the break as they were too far away from bc children's hospital. As the patient was not at their normal facility, the lot number for the tpn catheter is unknown. Upon inspection initially in the emergency department by a unit 1 rn certified in line repair, a break larger than 1 cm was noted along the length of the line, in the thicker part of the line. The repair was completed by the unit 1 rn, on unit 2 where the patient was admitted. The family came with a repair kit. The patient's activity level was described as active. No other adverse effects have been reported. Additional information regarding patient and event details has been requested but is not currently available.
 
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Brand NameREDO SINGLE LUMEN TPN CATHETER SET
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key11095303
MDR Text Key225343420
Report Number1820334-2020-02390
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 04/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberC-TPNS-3.0-65-REDO
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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