MAUDE Adverse Event Report: SMITHS MEDICAL, INC HIGH PRESSURE EXTENSION TUBE; DXT-ANGIOGRAPHIC INJECTOR AND SYRINGE

Catalog Number 601278

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A report was received stating that during use of the device, the high pressure tubing broke while connected to a pigtail catheter.No adverse effects to the pt or physician were reported.

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

• Brand Name: HIGH PRESSURE EXTENSION TUBE
• Type of Device: DXT-ANGIOGRAPHIC INJECTOR AND SYRINGE
• Manufacturer (Section D): SMITHS MEDICAL, INC; dublin OH
• Manufacturer (Section G): SMITHS MEDICAL; 6250 shier-rings road; dublin OH 43016
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4694457
• MDR Text Key: 16464698
• Report Number: 2183502-2015-00245
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2015
• Device Catalogue Number: 601278
• Device Lot Number: 2345165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2015
• Device Age: 30 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 58 YR