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

Catalog Number	C-UQLM-1001J-RSC-ABRM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set.(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 two cook spectrum minocycline/rifampin impregnated five lumen central venous catheters presented a fracture and reflux between medications and liquids used.The first device, subject of this report, was used from (b)(6) 2017.The second device, reported on medwatch 1820334-2018-02597, was used from (b)(6) 2017.Additional information with regards to the patient and event has been requested but not provided by the customer.As reported, the patient did not experience any additional adverse effects due to this occurrence.
Event or Problem Description
Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.This information is detailed in section additional narrative.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: event description: additional information was received on (b)(6) 2018 which detailed there was one patient involved in this event.A third catheter was required to be placed due to the fracture of the second device.Although requested, additional information regarding patient demographics, medical history, additional event details, and patient outcome have not been provided.Investigation - evaluation.A review of the complaint history, drawings, device history record, documentation, manufacturing instructions, specifications, and quality control was conducted during the investigation.A physical examination of the device could not be performed since no product was returned.A representative device from the same lot could not be acquired for evaluation.No photos were provided by the customer.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows two nonconforming events that could contribute to this failure mode.; however, these were scrapped and not released for distribution.A complaint history search revealed one other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be established.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed 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: 7834743
• Report Number: 1820334-2018-02596
• Device Sequence Number: 19469782
• Product Code: FOZ
• UDI-Device Identifier: 00827002431300
• UDI-Public: (01)00827002431300(17)180908(10)NS7731451
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K060174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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: 09/08/2018
• Device Catalogue Number: C-UQLM-1001J-RSC-ABRM
• Device Lot Number: NS7731451
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Outcome Attributed to Adverse Event: Required Intervention