MAUDE Adverse Event Report: BARD BARD PEDIATRIC URINE METER CATHETER TRAY; FOLEY CATHETER

Device Problems Break (1069); Disconnection (1171)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/04/2016

Event Type  malfunction  

Event Description

Premature newborn born with ruptured omphalocele.Large defect remained to the liver.Pt with oliguria necessitating foley catheter placement.Bard pediatric indwelling urine catheter placed by nursing staff with no complications.Foley intact and draining properly.During nursing assessment, the foley was found to be disconnected where the port meets the rod connection on the catheter.Foley was removed due to break in system that could compromise sterility and increase risk of infection.Per doctor orders, no new foley was placed.No harm or injury occurred.

• Brand Name: BARD PEDIATRIC URINE METER CATHETER TRAY
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): BARD; murray hill NJ
• MDR Report Key: 5569925
• MDR Text Key: 42500412
• Report Number: MW5061602
• Device Sequence Number: 1
• Product Code: EZL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13 DA
• Patient Weight: 2