MAUDE Adverse Event Report: COOK SPECTRUM; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number G44128

Device Problems Partial Blockage (1065); Fluid/Blood Leak (1250)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2021

Event Type  Injury  

Manufacturer Narrative

Brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray.Catalog number/rpn: c-utlmy-701j-rsc-abrm-hc-fst-a-rd.Initial reporter customer (person): line 2: (b)(6).(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 cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter was found to be leaking at the insertion site.The catheter was initially implanted on (b)(6) 2020 and began leaking on (b)(6) 2021.After the leak was noted, the device was replaced with no issues.No other adverse effects have been reported.Additional information has been requested regarding patient/event details but is not currently available.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.D10 ¿ product received on: (b)(6) 2021.Investigation ¿ evaluation.It was reported by hackensack meridian health, new jersey that the catheter began leaking at the insertion site.The complaint device was reported to be a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray (rpn: c-utlmy-701j-rsc-abrm-hc-fst-a-rd, lot number 13411570).The device was initially inserted on (b)(6) 2020.The catheter began leaking on (b)(6) 2020.The catheter was removed and replaced.No patient harm or adverse effects were reported.A review of the documentation including 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 triple-lumen cvc was returned for evaluation.No visible damage was noted to the device.A functional test found that lumen #1 did not leak, and lumens #2 and #3 were occluded.No splits or ruptures in the tubing were noted by the leak test.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls are in place to detect this failure mode prior to release.A review of the design history file (dhf) found that the risks of this device are acceptable when weighed against the benefits.A review of the device history record (dhr) for lot 13411570 and relevant catheter subassembly lot ic13277375 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 this lot number.As there are no related nonconformances or other complaints from 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 related to the reported failure mode: suggested catheter maintenance to prevent clotting or possibility or air embolus, the double lumen¿s #2 lumen, the triple-lumen¿s #2 and #3 lumens, and the five-lumens #2, #3, #4, and #5 lumens should be filled with saline solution or heparinized saline solution (100 units of heparin per ml of saline is usually adequate), depending on institutional protocol, prior to catheter introduction.Any unused lumens should be maintained with continuous saline or heparinized saline drip or locked with heparinized saline solution.Precautions: if lumen flow is impeded, do not force injection or withdrawal of fluids.Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.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, it was concluded that the cause of the event was due to a component failure without design or manufacturing deficiency.It is feasible to suggest that if the lumens were occluded and fluid was attempted to be injected through the unobstructed lumen, pressure may have built up within the catheter resulting in leakage at the insertion site.It is possible that biological matter caused the obstruction, but this cannot be confirmed without additional information regarding the type of saline/medications flushed through the device.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.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: COOK SPECTRUM
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 11336925
• MDR Text Key: 232196437
• Report Number: 1820334-2021-00343
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002441286
• UDI-Public: (01)00827002441286(17)211001(10)13411570
• Combination Product (y/n): Y
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

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: 10/01/2021
• Device Model Number: G44128
• Device Catalogue Number: C-UTLMY-701J-RSC-ABRM-HC-FST-A-RD
• Device Lot Number: 13411570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 08/31/2021
• Supplement Dates FDA Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention