MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERGLIDE PRO MIDLINE CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 00801741142666

Device Problems Break (1069); Positioning Problem (3009); Suction Failure (4039)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/10/2020

Event Type  Injury  

Event Description

Midline catheter was being placed via ultrasound and when rn unable to get a blood return or positive placement verification with wire advancement, the catheter was removed.Upon inspection of the catheter, the 2cm tip of the poly catheter was missing.Repeat elbow xray taken on (b)(6) 2020 and foreign body noted in the same place.Fda safety report id# (b)(4).

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC. ; salt lake city UT 84116
• MDR Report Key: 10534945
• MDR Text Key: 207160919
• Report Number: MW5096608
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741142666
• UDI-Public: (01)00801741142666
• 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: 09/11/2020

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: 01/31/2022
• Device Model Number: 00801741142666
• Device Catalogue Number: F120080T
• Device Lot Number: REEP4157
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Weight: 32