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

Catalog Number	C-TPNS-12.0D-90-REDO
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/16/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The information received indicated that the tip of the dilator was damaged during an insertion attempt.The reporter indicated that due to the extreme obesity of patient or curvature of vein and obstacle of clavicle, the appropriate twisting motion was used, at this point the introducer kinked and the tip of the dilator was damaged.Evaluation of the returned device indicated the dilator had been split beginning at the tip and extending 3mm proximally.The device had been split so that almost half the tip had detached at an angle, the second dilator had a 1mm split.A section of the device did not remain inside the patient¿s body.The procedure was completed with the use of a new set.According to the initial reporter the patient did not require any additional procedures due to this occurrence and the patient did not experience any adverse effects due to this event.

• Brand Name: REDO DOUBLE 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: 6764243
• Report Number: 1820334-2017-02220
• Device Sequence Number: 18884604
• Product Code: FOZ
• UDI-Device Identifier: 00827002080744
• UDI-Public: (01)00827002080744(17)170401(10)4882950
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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 Catalogue Number: C-TPNS-12.0D-90-REDO
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1