MAUDE Adverse Event Report: BARD ACCESS SYSTEMS OTW, 14.5 FR, 19CM. ST, SPLIT TIP, STANDARD KIT

Catalog Number 5903190

Device Problem Air Leak (1008)

Patient Problem Air Embolism (1697)

Event Date 05/08/2014

Event Type  Injury  

Event Description

There was an air embolism that was seen on post-op on the airguard.No harm to the patient.Two doctors experienced this with the same lot number on the same day from the same facility.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rexl1125 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (rex1125) have been reported from one u.S.Facility.

• Brand Name: OTW, 14.5 FR, 19CM. ST, SPLIT TIP, STANDARD KIT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; salt lake city UT
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: christy chandonia ; 605 north 5600 west; salt lake city, UT 84116 ; 8015224969
• MDR Report Key: 3876020
• MDR Text Key: 4513022
• Report Number: 3006260740-2014-00272
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090101
• 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: 05/09/2014

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 Catalogue Number: 5903190
• Device Lot Number: REXL1125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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
• Patient Outcome(s): Required Intervention