MAUDE Adverse Event Report: BARD ACCESS SYSTEM INC. POWERGLIDE PRO MIDLINE RT CATHETER 18G 8CM; CATHETER, INTRAVASCULAR, TERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number F118088PT

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

Patient Problem Tissue Damage (2104)

Event Date 10/11/2018

Event Type  Injury  

Event Description

Powerglide pro 18g 8cm midline catheter broke off hub in subcutaneous tissue of pt.Add'l procedure needed for tedious exploration to remove hub with tip intact.Filled complaint with bd bard's quality file# (b)(4).Investigation letter was received that we don't agree on.Fda safety report id# (b)(4).

• Brand Name: POWERGLIDE PRO MIDLINE RT CATHETER 18G 8CM
• Type of Device: CATHETER, INTRAVASCULAR, TERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEM INC. ; salt lake city UT 84116
• MDR Report Key: 9295472
• MDR Text Key: 166123258
• Report Number: MW5090963
• Device Sequence Number: 1
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: F118088PT
• Device Lot Number: RECU0552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 70