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

Catalog Number	412290401
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to return for evaluation.The reported complaint cannot be confirmed without the returned sample.
Event or Problem 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.
Additional 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
• Common Device Name: CATHETERS AND ACCESSORIES
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT 84123
• MDR Report Key: 8191251
• Report Number: 1713468-2018-00000
• Device Sequence Number: 2279955
• Product Code: DQE
• UDI-Device Identifier: 00840619044015
• UDI-Public: (01)00840619044015(17)200201(10)92-795-Y1
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K091268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: 412290401
• Device Lot Number: 92-795-Y1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1