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

Catalog Number	C-UTLM-701J-ABRM-HC-RD
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.Catalog number: c-utlm-701j-abrm-hc-rd.Patient code: no code available - patient will require a line replacement procedure.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 a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter (cvc) hub was found cracked.The patient will require a line replacement procedure when conditions permit.As reported, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the complaint device was not returned for an evaluation.Without the complaint device, a device failure analysis was unable to be performed.No photos were provided.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use (ifu), manufacturing instructions, and quality control data.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no notable gaps in production or processing controls were noted.The device history records for the device, its applicable subassemblies, components and raw materials were reviewed.One noteworthy non-conformance in component one: (b)(4), lot: ic8638741 was noted for failed test, leakage.Due to the individual nature of this manufacturing process, a non-conformance in one device does not indicate non-conformances in the rest of the lot.In addition, the affected device was scrapped.All other devices were leak tested as well.A search of complaint records determined that there were no other complaints reported for lot number 8858720.There have been no complaints associated with any of the subassemblies, components, or raw material lots used in the manufacture of this device.The instructions for use (ifu) c_t_ctulmabrm_rev7 [cook spectrum central venous catheter minocycline/rifampin antibiotic impregnated power injectable] states device description, intended use, contraindications, warnings, precautions, suggested catheter maintenance, instructions for use, and how supplied for the device.It specifically states: do not re-sterilize catheter.Do not cut, trim or modify catheter or components prior to placement or intraoperatively.How supplied.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.A supplier evaluation was performed.According to the supplier investigation: the location of the crack was not provided, but is assumed along the weld line like other cracked hub reports.The weld line of the hub is the hub's weakest feature.If the male luer fitting is over engaged in the female luer taper of the hub, the weld line can be prone to cracking due to excessive force.Reviewed the manufacturing logs of hub lots.No anomalies were noted in the manufacturing process; parameters were within validated manufacturing specifications.No evidence exists to assume parts do not meet specification.Inspections performed during manufacturing yielded no parts out of specification.No non-conforming product has been identified in-house or in the field based on this investigation.Per the supplier, the hub fractured because the hub's weld line strength was exceeded by forces exerted from over engagement of male luer fitting.Measures have been initiated to investigate this failure mode.Cause has not been established.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required at this time.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
Event or Problem Description
There has been no new information received since the last report was submitted.

• 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: 7899062
• Report Number: 1820334-2018-02743
• Device Sequence Number: 19262958
• Product Code: FOZ
• UDI-Device Identifier: 00827002478251
• UDI-Public: (01)00827002478251(17)210312(10)8858720
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: 03/12/2021
• Device Catalogue Number: C-UTLM-701J-ABRM-HC-RD
• Device Lot Number: 8858720
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 01/16/2019
• 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: Other