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	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that the tip of guide wire holder from a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set was broken.The event was noted prior to patient contact.There are no reported adverse patient consequences.The device is reportedly available for evaluation, however it has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
Additional information: brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.Corrected information: device was received on 23jun2017, after the initial report was submitted.Investigation - evaluation : a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set device was returned in opened, and unused condition.The tip of the wire guide holder was broken into two separate pieces.The wire guide dispenser material was lodged in the j-tip straightener; the fragment was removed in order to take measurements.The od of the snap on the dispenser and the id of the snap end of j-ip straightener measured within specification limits.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 no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.The wire guide holder is introduced in the package during the packaging stage of the product.The j-tip straightener is snapped to the wire guide dispenser prior to shipping.The package is inspected for defects during the packaging and post sterilization stages.Based on the information provided, examination of the returned product, and the results of our investigation, the root cause for the broken tip is likely related to handling during the packaging, sterilization, transportation or storage of the device.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6660053
• Report Number: 1820334-2017-01362
• Device Sequence Number: 750459
• Product Code: FOZ
• UDI-Device Identifier: 00827002536005
• UDI-Public: (01)00827002536005(17)190204(10)6998017
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K033843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

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 Model Number: N/A
• Device Catalogue Number: C-UTLM-701J-RSC-ABRM-HC-RD-P
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1