MAUDE Adverse Event Report: COOK, INC REDO DOUBLE LUMEN TPN CATHETER SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number C-TPNS-7.0D-65-REDO

Device Problem Leak/Splash (1354)

Patient Problem Surgical procedure, additional (2564)

Event Date 08/04/2014

Event Type  Injury  

Event Description

Per complaint form: "tpn-line broken distal of the y-manifold.However, tpn-line was already placed on (b)(6) 2014 -- customer thinks broken tpn-line due to wrong handling.Customer tried to repair tpn-line with repair-set, but failed.A new tpn line was placed the same day." rep has advised that "that this complaint is not related to bad quality of the product.Tpn-line was already placed on (b)(6) 2014 and customer thinks that rupture was caused during manipulation of tpn-line.A section of the device did not remain inside the pt's body.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event is still under investigation.

• Brand Name: REDO DOUBLE LUMEN TPN CATHETER SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK, INC; bloomington IN 47404
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4071235
• MDR Text Key: 17292012
• Report Number: 1820334-2014-00402
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: C-TPNS-7.0D-65-REDO
• Device Lot Number: 4548339
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/04/2014
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/06/2014
• Initial Date FDA Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention