MAUDE Adverse Event Report: HOSPIRA LTD. EXT SET 7IN REM CLAVE SITE NDEHP; 80FPA

Catalog Number 14929

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2014

Event Type  malfunction  

Event Description

The customer contact reported a tubing split while in use with a power injector.It was reported that during a ct scan, the extension tubing set was being used to deliver an unspecified contrast solution at an unspecified rate, via a power injector.After an unspecified length of time, the customer contact reported the tubing split during injection.No specific details were provided.The procedure was aborted.There were no reports of any adverse patient effects or delay in therapy critical to the patient.No medical interventions were reported.Though requested, no additional information was provided including if the procedure was rescheduled.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.This report represents all the information known by the reporter upon query by hospira personnel.

• Brand Name: EXT SET 7IN REM CLAVE SITE NDEHP
• Type of Device: 80FPA
• Manufacturer (Section D): HOSPIRA LTD.; carretera sanchez, km 18 1/2; parque industrial; haina, san cristobal ; DR
• Manufacturer (Section G): HOSPIRA LTD.; carretera sanchez, km 18 1/2; parque industrial; haina, san cristobal ; DR
• Manufacturer Contact: juergen schmider, md, vp ; 275 n. field drive; bldg no h2-1east dept no 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4156225
• MDR Text Key: 17994377
• Report Number: 9613251-2014-00142
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 14929
• Device Lot Number: 410644W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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
• Treatment: UNSPECIFIED POWER INJECTOR, MFG UNK
• Patient Age: 53 YR
• Patient Weight: 90