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

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray.Occupation: director, supply chain.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the blue port of a cook spectrum minocycline/rifampin impregnated double lumen central venous catheter cracked during an ethanol lock.The catheter was removed from the patient and replaced with another device.As reported, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Device received on: 07aug2019.Investigation/evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions (mi), quality control, and specifications, as well as a functional test, dimensional verification, and a visual inspection of the returned device were conducted during the investigation.One 5fr double lumen catheter was returned to cook for investigation.Physical examination of the device showed that two competitor caps were on the fittings and that biological matter was present.A crack was observed on the blue hub.No other surface damage was noted.A leak was confirmed on the blue hub as well.The complaint was able to be confirmed based on customer testimony and the returned device.Cook has concluded that there is no evidence suggesting that the device was manufactured out of specification.Additionally, a document-based investigation evaluation was performed.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record for lot 7578022 found no non-conformances related to this failure mode.A trackwise search found no additional complaints from this lot as well.This suggests that there is no evidence of nonconforming product from this lot in house or in field.Cook also reviewed product labeling for the complaint device.The product ifu, [c_t_ulmabrm] ¿spectrum and spectrum glide central venous catheters,¿ provides the following information to the user related to the reported failure mode: suggested lumen utilization: double lumen.¿#1 distal exit port (endhole) ¿ whole blood or blood product delivery and sampling; any situation requiring more flowrate; cvp monitoring; medication delivery.It is strongly recommended that this lumen be used for all blood sampling." "#2 proximal exit port ¿ medication delivery; acute hyperalimentation.¿ suggested catheter maintenance: ¿any unused lumens should be maintained with continuous saline or heparinized saline drip or locked with heparinized saline solution.Heparin-locked lumens should be reestablished at least every 8 hours."before using any lumen already locked with heparin, lumen should be flushed 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.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned product, and the results of the investigation, a definitive root cause could not be established.Appropriate measures are being conducted to address this failure mode.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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 or Problem Description
Additional information was received on 25sep2019 stating that the fitting was not connected to anything and is not available for return.The customer is unable to provide the length of time the device was in place.There was no force exerted on the catheter.

• Brand Name: COOK SPECTRUM
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8871650
• Report Number: 1820334-2019-01956
• Device Sequence Number: 16190187
• Product Code: FOZ
• UDI-Device Identifier: 00827002439825
• UDI-Public: (01)00827002439825(17)190501(10)7578022
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K033843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2019
• Device Model Number: N/A
• Device Catalogue Number: C-UDLMY-501J-PED-ABRM-HC-FST
• Device Lot Number: 7578022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention