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

Catalog Number C-TPNS-7.0D-65-REDO

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Code Available (3191)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(6).Occupation: clinical safety coordinator.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

It was reported that a redo double lumen tpn catheter had split in 2 places along the catheter.There was resistance felt while flushing the catheter, as the bedside nurse described the lumens to be "sluggish".The nurse then "heard a 'pop'" when flushing the yellow lumen and discovered 2 breaks in both lumens of the catheter.The patient required peripheral iv insertion for iv access as the line was not functional.In this time, the patient missed their morning bloodwork that was to be drawn from the line.The catheter was repaired with a cook double lumen repair kit and verified to be functional post-repair.Additional information regarding event details has been requested but is currently unavailable.No other adverse effects have been reported for this incident.

Event Description

Additional information regarding the event, patient, and device was received on 13feb2020.The placement site for the catheter was the patient's right femoral.The bedside nurse used the device to perform blood withdrawal via the reinfusion method.Beforehand, the device was used for tpn and iv medications/solutions.The device was secured to the patient using transparent dressing (the catheter was coiled under the dressing).At the time of the incident, the patient was on bed rest.

Manufacturer Narrative

Concomitant medical product: extension tubing, injection caps (medical microclave clear) on lumens, 10cc syringes, 10 cc prefilled ns flush syringes, double stopcocks, alaris iv tubing.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional patient/event details have been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported that the catheter from a redo double lumen tpn catheter set (part number c-tpns-7.0d-65-redo, lot number unknown) was being flushed when it "popped".The bedside nurse was flushing the lumen with a yellow hub when they heard a pop and discovered 2 breaks in the catheter on both lumens.The patient required a peripheral insertion for iv access while the line was not functional and being repaired.A cook double lumen repair kit was used to repair the device and the catheter was verified as functional after the repair.The placement site for the catheter was the patient's right femoral.The bedside nurse was performing blood withdrawal via the reinfusion method.Beforehand, the device was used for tpn and iv medications/solutions.The device was implanted on 05jun2019 and secured to the patient using transparent dressing (the catheter was coiled under the dressing).At the time of the incident, the patient was on bed rest.While this device is not sold in the u.S., same/similar devices include cook piccs (upic[d][t]s-) and cvcs (c-ud[t][q]lm[y]-), thus prompting this report.A review of the complaint history, instructions for use (ifu), and quality control, as well as a visual inspection and functional test of the returned device were conducted during the investigation.The complaint device was returned for evaluation.The device examination found the tubing had separated on the large lumen hub and the adhesive rings on both winged hubs had separated.Flushing of the lumens noted no leakage on the device.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the risk assessment for this failure mode found that the risks associated with the devices are acceptable when weighed against the benefits.A review of the device history record could not be completed due to a lack of lot information from the user facility.There is no evidence to suggest there is any nonconforming product in house or out in the field.A review of the product labeling for the device was also completed.The instructions for use state the following instructions related to the reported failure mode: -silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10ml syringe or larger will reduce the risk of catheter rupture.The following suggested catheter maintenance is also provided ¿.If catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with heparinized saline solution.Normal saline lock is permissible if utilizing the clc2000 injection cap.Catheter heparinization should be determined by institutional protocol and clinical judgement.Heparin concentrations of 10 units/ml to 100 units/ml have been reported adequate to maintain lumen patency.Catheter lock should be reestablished after every use or at least every 24 hours if unused.Before using catheter lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin or saline lock.Strict aseptic technique must be adhered to while using and maintaining catheter.Based on the information provided, inspection of the returned product, and the results of the investigation, a definitive cause for failure was not established.Separation and leakage of the device are known inherent risks of device usage.The appropriate personnel have been notified.Previous corrective and preventative action was taken to address this failure mode and found that the product line meets specifications.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.

• Brand Name: REDO DOUBLE 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: 9688469
• MDR Text Key: 192373612
• Report Number: 1820334-2020-00321
• 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,Followup
• Report Date: 04/17/2020

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 Catalogue Number: C-TPNS-7.0D-65-REDO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 02/13/2020; 04/13/2020
• Supplement Dates FDA Received: 03/02/2020; 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1