MAUDE Adverse Event Report: COOK INC REDO SINGLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/16/2016
Type of Reportable Event	Serious Injury
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 a previously repaired catheter broke.The patient underwent an additional procedure to remove and replace the broken catheter.No further event details were provided.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that there was a hole in the device which may have resulted in a leak.Additionally, the tubing which was glued to the hub had separated, allowing the hub to spin.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there was only one other reported complaint for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: REDO SINGLE LUMEN TPN CATHETER SET
• 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: 6255616
• Report Number: 1820334-2017-00006
• Device Sequence Number: 413517
• Product Code: FOZ
• UDI-Device Identifier: 00827002079335
• UDI-Public: (01)00827002079335(17)171105(10)5357904
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-6.5-90-REDO
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 06/27/2017
• 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
• Patient Age: 5 YR