MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC BARD POWERGLIDE PRO MIDLINE CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM

Model Number F120101

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2019

Event Type  Injury  

Event Description

Nurse attempting to place a powerglide pro midline catheter.Unable to thread catheter when pulling wire back, nurse noted it appeared to be bent.Nurse fully removed wire and compared it with two other midline kits.The nurse then noted that the wire appeared to be shorter than the others.No patient harm.

• Brand Name: BARD POWERGLIDE PRO MIDLINE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC
• MDR Report Key: 8366819
• MDR Text Key: 137298388
• Report Number: MW5084327
• Device Sequence Number: 0
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 02/21/2019

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
• Device Expiration Date: 12/31/2019
• Device Model Number: F120101
• Device Catalogue Number: F120101
• Device Lot Number: RECX1010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention