MAUDE Adverse Event Report: C. R. BARD, INC. POWERPORT DUO MRI IMPLANTABLE PORT CATHETER; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS INTRAVASCULAR

Model Number 1829500

Device Problem Radiation Leak (1357)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2019

Event Type  malfunction  

Event Description

Powerloc port-a-cath needle tubing began leaking at juncture of flexible tubing with hard plastic of proximal lumen.Chemo leaked onto pt / bed / clothing.Spill cleaned, port de- and re-accessed.Chemotherapy restarted (cytarabine 100 mg/m2; sodium chloride 0.9) iv piggyback.Ref mfr report # 3006260740-2019-03966.

• Brand Name: POWERPORT DUO MRI IMPLANTABLE PORT CATHETER
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS INTRAVASCULAR
• Manufacturer (Section D): C. R. BARD, INC. ; covington GA 30014
• MDR Report Key: 9659261
• MDR Text Key: 177675524
• Report Number: MW5092703
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027185
• UDI-Public: (01)00801741027185
• Combination Product (y/n): N
• 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: 11/27/2019

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: 10/31/2020
• Device Model Number: 1829500
• Device Catalogue Number: 1829500
• Device Lot Number: REDP3364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2020
• 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 Age: 68 YR
• Patient Weight: 92