MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. MEDEX ULTRA EXTENSION SET W/0.2 MICRO FILTER; FPB - INTRAVASCULAR ADMINISTRATION SET

Catalog Number MX448HF

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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 extension set was observed to be cracked and leaking at the filter.The report states that, due to the leakage, the pt's blood had backed into the tubing up to the filter.The report states that there was a delay in therapy while the clinician exchanged the set.No incident related medical sequelae were reported.

Manufacturer Narrative

Customer has not yet returned the device to the mfr for device eval.When and if the device becomes available and is returned and evaluated, the mfr will file a f/u report detailing the results of the eval.

• Brand Name: MEDEX ULTRA EXTENSION SET W/0.2 MICRO FILTER
• Type of Device: FPB - INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; dublin OH
• Manufacturer (Section G): SMITHS MEDICAL; 6250 shier-rings road; dublin OH 43016
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3814999
• MDR Text Key: 22138732
• Report Number: 2183502-2014-00254
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K860803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/25/2014,04/25/2017

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: MX448HF
• 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: 04/25/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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