MAUDE Adverse Event Report: ICU MEDICAL, INC. TD CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED; CATHETERS AND ACCESSORIES

Catalog Number 412290401

Device Problem Material Rupture (1546)

Patient Problem Injury (2348)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to return for evaluation.The reported complaint cannot be confirmed without the returned sample.

Event Description

The event involved a td catheter, 7f, 4 lumen, 110 cm, heparin coated that was reported that the balloon burst open when used.There was a report of an unspecified injury.No additional details were provided.

Manufacturer Narrative

Testing and investigation confirmed there were no product samples or photographs returned for investigation.Therefore, the complaint could not be confirmed and a complete investigation was not performed without the sample or mating device.A manufacturing batch record review was completed and there were no non-conformances found that would have contributed to the reported event.

• Brand Name: TD CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED
• Type of Device: CATHETERS AND ACCESSORIES
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT 84123
• MDR Report Key: 8191251
• MDR Text Key: 131942447
• Report Number: 1713468-2018-00000
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00840619044015
• UDI-Public: (01)00840619044015(17)200201(10)92-795-Y1
• Combination Product (y/n): N
• PMA/PMN Number: K091268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

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: 02/01/2020
• Device Catalogue Number: 412290401
• Device Lot Number: 92-795-Y1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1