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

Catalog Number C-UTLM-701J-RSC-ABRM-HC-RD

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2020

Event Type  malfunction  

Manufacturer Narrative

Brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.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 every lumen in a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter had occluded except for the blue one.Additional information regarding event details has been requested but is not currently available.No other adverse effects have been reported for this incident.

Event Description

In additional information received on 20apr2020, it was reported that all lumens were filled with saline or heparinized saline before introduction into the body.Nutrition medicine was being administered through the device.The physician used saline to flush the unused lumen and then locked it.Maintenance protocol was provided.After cvc initial procedure, all lumens will be flushed with saline and clamps are used to lock the lumens.If the physician needs to inject drugs for the patient, it will be determined if blood will flow to the needle to confirm that the catheter is not occluded.If everything is fine, the drug will be injected.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported that a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set (c-utlm-701j-rsc-abrm-hc-rd) from lot 9472579 had obstructed lumens seven days after placement.All lumens except for the blue one were obstructed.Cook became aware of this event on (b)(6) 2020 upon being notified by (b)(6) hospital.The patient reportedly experienced no adverse effects as a result of this incident.A review of documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions 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 central venous catheter was returned for evaluation.The distal tip of the catheter had been cut off.Two cook microclaves were returned attached to the blue and white hubs.A third-party connector cap was attached to the red hub.All three lumens were able to be flushed with no issues.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient controls are in place to detect this failure mode prior to release.The risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record for lot 9472579 showed no nonconformances.One related nonconformance was discovered in subassembly lot ic9348213 for abrm coating inside the diameter of the catheter, in which one device was scrapped.It should be noted that there were no additional complaints associated with lot 9472579 at the time of the investigation.There is no evidence to suggest 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: "suggested catheter maintenance.To prevent clotting or possibility of air embolus, the double-lumen¿s #2 lumen, the triple-lumen¿s #2 and #2 lumens, and the five-lumen¿s #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.Before using any lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumens should be flushed with normal saline between administrations of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin lock." based on the information provided, examination of the returned product and the results of our investigation, it was concluded that possible use error potentially contributed to the failure.The customer stated that saline was used to flush and lock unused lumens.It is unclear whether or not the saline was heparinized.The ifu suggests using heparinized saline if the lumens are to be locked, or using a saline drip with non-heparinized saline.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
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9757066
• MDR Text Key: 181959519
• Report Number: 1820334-2020-00470
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002478299
• UDI-Public: (01)00827002478299(17)211203(10)9472579
• Combination Product (y/n): N
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2021
• Device Catalogue Number: C-UTLM-701J-RSC-ABRM-HC-RD
• Device Lot Number: 9472579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 62