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

Model Number	G43995
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: cook spectrum minocycline/rifampin impregnated double 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 a cook spectrum minocycline/rifampin impregnated double lumen central venous catheter set was used as a central line for postoperative management.The device was inserted and occlusive clamps were found missing.The device was removed and a like device was inserted utilizing a guide wire in at the same insertion site.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
H6: patient code: no code available - device was removed and replaced with a like device.Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.The catheter was returned and was found to be missing occlusive clamps.Per manufacturing instructions, the device was visually inspected by quality control and no notable gaps in production or processing controls were noted.The device history record was reviewed and no related non-conformances were noted.Additionally, a search of our complaint records indicates that this is the only complaint on the lot number at the time of investigation.The investigation conclusion was found to be quality control related.Per the [quality engineering] risk assessment, production and quality control were notified for retraining.Monitoring will continue to be performed 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.

• 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: 7657955
• Report Number: 1820334-2018-01851
• Device Sequence Number: 14110680
• Product Code: FOZ
• UDI-Device Identifier: 00827002439955
• UDI-Public: (01)00827002439955(17)200823(10)8314144
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K033843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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: 08/23/2020
• Device Model Number: G43995
• Device Catalogue Number: C-UDLM-501J-ABRM-HC
• Device Lot Number: 8314144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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