MAUDE Adverse Event Report: BARD MINILOC-PORT NEEDLE, 20G 1.0 IN.

Lot Number ASYES228

Device Problems Crack (1135); Reflux within Device (1522)

Patient Problem Blood Loss (2597)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

Port needle malfunctioned, potential crack in needle causing blood to back up through the top of the needle.

• Brand Name: MINILOC-PORT NEEDLE, 20G 1.0 IN.
• Type of Device: MINILOC-PORT NEEDLE, 20G 1.0 IN.
• Manufacturer (Section D): BARD
• MDR Report Key: 4199050
• MDR Text Key: 17631040
• Report Number: MW5038772
• Device Sequence Number: 1
• Product Code: FMI
• 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: 10/17/2014

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 Expiration Date: 05/01/2017
• Device Lot Number: ASYES228
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR