MAUDE Adverse Event Report: BD BD DIFFUSICS PERIPHERAL CATHETER

Model Number UNAVAILABLE

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2016

Event Type  malfunction  

Event Description

Pt had a peripheral catheter that was inserted to right antecubital as a saline lock.Noted the tip of the saline locked catheter broke off right below the clamp and noted laying in the bed.The iv catheter was intact upon assessment by the rn.Possible catheter/equipment malfunction because the catheter should not have broken off from a saline locked tubing.No harm to pt.

• Brand Name: BD DIFFUSICS PERIPHERAL CATHETER
• Type of Device: BD DIFFUSICS PERIPHERAL CATHETER
• Manufacturer (Section D): BD; franklin lake NJ 07417
• MDR Report Key: 6099100
• MDR Text Key: 59900458
• Report Number: MW5065983
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 83