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	Hole In Material (1293)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This malfunction is related to a previous event reported via mdr# 1820334-2017-00006.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 customer reported that the previously repaired single lumen tpn catheter broke.This device was initially implanted on (b)(6) 2016.The patient underwent an additional procedure on 12/16/2016 to remove and replace the broken catheter.This event was previously reported in mdr# 1820334-2017-00006.During the preliminary investigation of the broken catheter, it was noted that there was a hole in it that was not related to the previously reported break.A hole was found in the catheter separate from and not related to the previously reported break.The circumstances, conditions and etiology of this hole in the material is not known.The presence of this observed hole has the potential to result in a leak from the device.This report is to capture the malfunction of the hole not previously reported.
Additional Manufacturer Narrative
Investigation - evaluation.A review of device history record, specifications, complaint history, instructions for use (ifu), and visual inspections was conducted during on the returned product during the investigation.One single lumen silicone catheter was returned with medical tape in the clamped region of the device.Removal of the medical tape exposed a hole through the side wall of the catheter.The hole is located 3.5mm from the tubing-to-manifold connection.Glue appears to have been completely around the device between the tubing and the hub.The glue bond between the tubing and the hub is completely separated.Cuff is still present and secure.The clamp is present and can be engaged and disengaged.No roughness was observed at the clamping surface.The catheter appears to have been trimmed to length by the physician per the ifu.The device was returned with a needless white and clear connector with a leur lock fitting.The device is supplied with a different connector.The connector returned with the device appears to twist on and off readily.It was noticed that the tubing that is glued to the hub had separated from the hub, allowing the hub to spin.There was a hole in the device that would have likely resulted in a leak.The redo single lumen tpn catheter set is shipped with instructions for use (ifu), which clearly state the proper warnings, precautions, and instructions for use with each device.Specifically; ¿silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10ml syringe or larger will reduce the risk of catheter rupture.If lumen flow is impeded, do not force injection or withdrawal of fluids.Catheter size should be as small as the use will allow¿.A thorough review of the device history record did not observe any non-conformances that may have contributed to this incident associated with the complaint lot number.A complaint history search revealed one other complaint associated with the lot number; 5357904.(b)(4) (broken device) was the first of two (2) related records to cover the initial failure mode.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Measures have been conducted to address this failure mode.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: 6352661
• Report Number: 1820334-2017-00276
• Device Sequence Number: 16444196
• Product Code: FOZ
• UDI-Device Identifier: 00827002079335
• UDI-Public: (01)00827002079335(17)171105(10)5357904
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2017

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: 01/24/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR