MAUDE Adverse Event Report: BARD POWERGLIDE 8CM MIDLINE CATHETER

Lot Number REZK0553

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/13/2016

Event Type  Injury  

Event Description

Powerglide midline being inserted into the left upper arm.Pt suddenly moved entire body and left arm.Midline became imbedded in the left arm.Unable to withdraw midline or disengage.Surgery consulted incision made at midline entry site and the midline was successfully removed intact.One suture required to close incision.Pt tolerated the procedure well.

• Brand Name: POWERGLIDE 8CM MIDLINE CATHETER
• Type of Device: POWERGLIDE 8CM MIDLINE CATHETER
• Manufacturer (Section D): BARD; salt lake city UT 84116
• MDR Report Key: 5454794
• MDR Text Key: 38881169
• Report Number: MW5060394
• 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: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: REZK0553
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 80