MAUDE Adverse Event Report: COOK INC TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET; DQY CATHETER, PERCUTANEOUS

Model Number G04135

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 09/13/2020

Event Type  Injury  

Manufacturer Narrative

Customer (person): mobile: (b)(6).Pma/510(k) #: preamendment.(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 crack was noted on the blue hub of a triple lumen polyurethane central venous catheter set following placement.The device was implanted through the patient's right femoral vein on (b)(6) 2020 and after "patient care compromise", the attending physician found the clamp on the white hub lumen to be missing and the blue hub lumen to be cracked and leaking medication.The crack was discovered on (b)(6) 2020 "with ceftriaxone acydorin and central venous flushing".Following, the blue lumen was locked and another peripheral line was inserted for medication infusion.Adverse effects to the patient also included a delay in medication and the "need to cannulate another central line".When asked to elaborate on the term "patient care compromise", the customer stated that the crack in the lumen prevented the infusion of urgent medication to the patient.The medication was not able to be infused as planned because the patient's blood pressure would have been affected.There was no power injection attached to the blue lumen.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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

In additional information received on 29sep2020, it was reported that the device's indication for placement was for administration of inotropes.Urgent medication could not be infused as planned.A 24-hour infusion pump was attached to the device to prevent backflow.The white lumen was still able to be used despite the cracked hub on the blue lumen of the device.The device was secured to the patient using "plaster.".

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation - evaluation it was reported that the catheter from a triple lumen polyurethane central venous catheter set (c-utlm-501j) from lot 8666198 had a cracked hub.Specifically, the blue hub was cracked, resulting in medication leakage and inability to infuse medication as planned.Another device had to be placed.Cook became aware of this event on 17sep2020 upon being notified by (b)(6) univ.(b)(6).The patient reportedly experienced no additional adverse effects as a result of this incident.A review of the complaint history, device history record (dhr), instructions for use (ifu) and quality control, as well as a visual inspection and functional test of the returned device, was conducted during the investigation.One used catheter was returned to cook for evaluation.Upon visual inspection, the extension tube connected to the white hub was noted to be missing a clamp.The extension tube connected to the blue hub was found to be cracked at the hub/line connection point on the right side.A functional leak test was performed and confirmed leakage at the site of the crack.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (8666198) and the related catheter subassembly lot revealed no recorded non-conformances.A database search found one additional event reported for the complaint device lot for an unrelated failure mode.As there are no non-conformances or other complaints for the same failure mode from this lot, there is no evidence that nonconforming product exists either in house or in the field.Cook also reviewed product labeling.Instructions for use (ifu) document [uncoated and heparin-coated central venous catheters] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: ¿warnings do not power inject contrast medium through catheter.Catheter rupture may result.Use of 10 ml or larger syringe will reduce the risk of catheter rupture.Precautions if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.How supplied upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, evaluation of the returned product, and the results of the investigation, a definitive root cause was unable to be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Appropriate measures have been initiated to address this failure mode.A capa is currently open to further investigate this failure mode in relation to this device.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: TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10614491
• MDR Text Key: 209448107
• Report Number: 1820334-2020-01793
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00827002041356
• UDI-Public: (01)00827002041356(17)210314(10)8666198
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2021
• Device Model Number: G04135
• Device Catalogue Number: C-UTLM-501J
• Device Lot Number: 8666198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 11/09/2020; 09/29/2020
• Supplement Dates FDA Received: 11/11/2020; 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 24-HOUR INFUSION PUMP
• Patient Outcome(s): Required Intervention
• Patient Age: 19 MO
• Patient Weight: 7