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

Model Number N/A

Device Problem Crack (1135)

Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330); No Code Available (3191)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).Occupation: unknown.Pma/ 510(k) #: pre-amendment.The patient required additional medication and additional procedure to remove and replace the device to preclude permanent impairment/death.Additionally, the patient experienced a delay in receiving treatment.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that a crack was discovered by a nurse on one of the catheter lumens of a triple lumen polyurethane central venous catheter set approximately 12 hours after insertion over the patient's right femoral vein, allowing for the backflow of blood.Consequently, there was a delay in medication infusion as well as discomfort experienced by the patient.Ultimately, due to inadequate lumens to infuse medication, the device was removed and replaced into the patient's right internal jugular.Following the discovery of the crack, the patient required medicine to stop "continuous bleeding".It was also reported that the patient was unable to move.Additional information regarding the device has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.It was reported that a triple lumen polyurethane central venous catheter set (c-utlm-501j) from lot 8776962 was cracked.This was noticed twelve hours after the catheter was inserted, resulting in a backflow of blood.The device had to be removed and replaced, causing a delay in medication infusion.Cook became aware of this event on 09jun2020 upon being notified by pusat perubatan univ.Mal.The patient reportedly experienced no additional adverse effects as a result of this incident.A review of documentation including the complaint history, device history record, instructions for use (ifu) and quality control, as well as a visual inspection of the returned device was conducted during the investigation.One used and damaged 5fr triple lumen catheter was returned for evaluation.Upon a physical examination, it was noted that the blue hub was cracked along one of the wings.One of the manifold wings was also found to be bent.No other damage to the device was observed.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient controls are in place to detect this failure mode prior to release.A review of the design history file (dhf) showed that the risks of this device are acceptable when weighed against the benefits.A review of the device history record (dhr) for lot 8776962 and catheter subassembly lots found no related nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the device lots at the time of this investigation.Since there are no related nonconformances or additional complaints for this lot, there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to 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, examination of the returned product and the results of our investigation, a definitive root cause could not be established.Appropriate measures have been taken to address this failure mode, as a capa is currently opened to address the issue of cracked hubs in this product line.The appropriate personnel have been notified.We 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 patient and/or event details has been received since the previous medwatch report was sent.

• 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: 10152996
• MDR Text Key: 195124882
• Report Number: 1820334-2020-01131
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00827002041356
• UDI-Public: (01)00827002041356(17)210416(10)8776962
• 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
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2021
• Device Model Number: N/A
• Device Catalogue Number: C-UTLM-501J
• Device Lot Number: 8776962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 11