MAUDE Adverse Event Report: COOK INC COOK TPN TRIPLE LUMEN TPN CATHETER SET; 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 Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2017
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
The international customer reported that the cook tpn triple lumen tpn catheter broke too early.The catheter reportedly lasted for approximately 5 weeks before they broke; specific figures were not provided.Additional information has been requested from the customer, but none has yet been made available.The device is reportedly available for return, but as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Please reference related mfr.Report:1820334-2017-04464.Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that all three lumens pulled apart at the base of the wing fitting.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 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.
Event or Problem Description
The international customer reported that the cook tpn triple lumen tpn catheter broke too early.The catheter reportedly lasted for approximately 5 weeks before they broke; specific figures were not provided.Additional information has been requested from the customer, but none has yet been made available.The device is reportedly available for return, but as of the date of this report, no device has yet been received for evaluation.Additional information received identified a new picc line had to be placed as a result of the event.

• Brand Name: COOK TPN TRIPLE 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: 7139053
• Report Number: 1820334-2017-04540
• Device Sequence Number: 903064
• Product Code: FOZ
• UDI-Device Identifier: 00827002033191
• UDI-Public: (01)00827002033191(17)200130(10)7571014
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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-TPNS-8.0T-90
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 03/19/2018
• 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