MAUDE Adverse Event Report: BARD PER-Q-CATH; PICC LINE 4.0 FR DUAL LUMEN

Lot Number REYG2704

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2014

Event Type  Other  

Event Description

At the end of the picc insertion, rn noticed that one side of the securement wing was broken off.The broken piece was found on the sterile field.Catheter flushed with no leaking.Rn was able to secure catheter using starlock.Md notified.No harm to patient.

• Brand Name: PER-Q-CATH
• Type of Device: PICC LINE 4.0 FR DUAL LUMEN
• Manufacturer (Section D): BARD
• MDR Report Key: 4278622
• MDR Text Key: 5297000
• Report Number: MW5039252
• Device Sequence Number: 1
• Product Code: DQO
• 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: 11/19/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Lot Number: REYG2704
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR