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

Model Number	G23763
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray.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 while flushing the catheter included in the cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray, discolored fluid was discovered.The catheter was flushed with normal saline prior to insertion, and the user observed brown fluid upon flushing.The catheter did not make patient contact.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information regarding event details has been requested, but is not available at this time.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Additional information: d10: product received on 07mar2019.H6 ¿ results code: appropriate term/code not available (4247) ¿ customer dissatisfaction.Investigation - evaluation: a review of the complaint history, device history record, instructions for use, manufacturing instructions, quality control, as well as a functional test and visual inspection of the returned device was conducted during the investigation.One triple lumen catheter with a stiffener located in the lumen of the red hub was returned for investigation.Only two needleless connectors were returned.Potential biological matter was present within the blue and white hub extension tubes.No surface damage was noted on the device, and the sideports appeared to be unobstructed.The stiffener was removed from the device, and it was observed to contain brownish discoloration on the surface.No damage was observed on the red, white or blue hubs.Each hub was flushed with room temperature water, and no resistance was noted when flushing any of the hubs.The red and white hub flushed clear liquid, however, the blue hub flushed with slightly discolored liquid.No resistance was felt when flushing either of the needleless connectors.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient activities are in place to identify this failure mode prior to device distribution.A review of the device history record for lot 8881926 showed no nonconformances.It was revealed that four nonconformances were found for complete catheter lot ic8563694.One nonconformance was determined to be unrelated to this incident.One nonconformance involved four devices with ¿coating in unspecified area,¿ in which all affected devices were scrapped.Another related nonconformance involved two devices with ¿coating on the manifold,¿ in which both devices were scrapped.The final nonconformance involved one device with ¿incorrect placement of marking (0-5cm).The affected device was scrapped.Complete catheter lot ic8593901 showed three nonconformances, as only one was found to be unrelated to this incident.One related nonconformance involved six scrapped devices with ¿coating in i.D¿, and another nonconformances affecting one device with ¿526 product contacted uncontrolled surface¿ that was later scrapped.In the final complete catheter lot ic8659844, three nonconformances were found.Two of those nonconformances were found to be unrelated to the incident.The one nonconformances that was related involved two devices with ¿251, incorrect coating length,¿ in which both devices were scrapped.Complete catheter lot ic8653069 showed zero nonconformances.It should be noted that there were no other complaints reported for lot 881926.It was concluded that 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: suggested catheter maintenance ".The antimicrobial agents minocycline and rifampin contain yell/orange pigments.Some coloration of the spectrum or spectrum glide catheters is normal." instructions for use ".Prepare the catheter for insertion by flushing each of the lumens." based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause could not be established.Most likely the device was flushing out excessive abrm coating.The ifu states that, ¿some coloration of the cook spectrum catheters is normal.¿ per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified and 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.

• 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: 8199017
• Report Number: 1820334-2018-03890
• Device Sequence Number: 19147208
• Product Code: FOZ
• UDI-Device Identifier: 00827002237636
• UDI-Public: (01)00827002237636(17)200323(10)8881926
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K081113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2020
• Device Model Number: G23763
• Device Catalogue Number: C-UTLMY-901J-ABRM-CUSTOM-0025
• Device Lot Number: 8881926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1