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	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2017
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
The international customer reported that, following placement of the device on (b)(6) 2017, the redo single lumen tpn catheter "appears fissured in the part where it narrows" [sic].The event was also translated as " cvc rupture - it appears split where it shrinks" [sic].The catheter reportedly ruptured along a narrow area of the device.No additional procedures were allegedly required as a result of this issue, and no patient adverse effects were reported.The product is reportedly available for return; however, as of the date of this report, no product has yet been received for evaluation.
Additional Manufacturer Narrative
Additional information: the device has been returned and evaluated.Investigation summary: a review of the complaint history, instructions for use(ifu), device history record, specifications, quality control, and a visual inspection of the returned device were conducted during the investigation.No systemic issues were found related to the reported complaint.One opened complaint device has been returned for investigation.A visual examination noted the seal between the tubing and the hub has pulled loose on the entire circumference.Additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances associated with the complaint device lot number.It should be noted there were no other reported complaints 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 cannot be determined.Per the risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• 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: 6894175
• Report Number: 1820334-2017-03256
• Device Sequence Number: 16346040
• Product Code: FOZ
• UDI-Device Identifier: 00827002079335
• UDI-Public: (01)00827002079335(17)191017(10)7221721
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2017

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-TPNS-6.5-90-REDO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 MO