MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SM ATT PLAS+8FR GROSH+KI; IMPLANTABLE PORT

Model Number 0602830

Device Problem Fluid/Blood Leak (1250)

Patient Problems Extravasation (1842); Caustic/Chemical Burns (2549)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical device - expiration date: 01/2023.

Event Description

It was reported that approximately one year post port device implant, the port allegedly leaked chemotherapy fluid and caused a burn.It was further reported that the port device was removed and a new port device was implanted.The patient status is unknown.

Event Description

It was reported that approximately one year post port device implant, during chemotherapy, an alleged port leak was identified, resulting in a burning sensation at an unknown location.It was further reported that the port device was removed and a new port device was implanted.The patient status is unknown.

Manufacturer Narrative

Manufacturing review: the lot met all release criteria.Dhr was reviewed and no deviations/issues were identified or associated with this problem in regards to product materials or during manufacturing, packaging or qc inspection process.Ll necessary inspections were performed throughout all manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot in regards to the described problem.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: one mri port with groshong catheter, the catheter being cut into two pieces with the proximal part still attached to the port using the cathlock, was returned for evaluation.The complete circumferential break was noted approximately 4.4cm from the distal end of the cath-lock and appeared to be cut using an instrument.A circumferential split was noted on the distal segment of the catheter.Functional evaluations were performed and both port body and catheter segments were patent with a leak observed at the circumferential split.The investigation is confirmed for the alleged leak, as a leaking circumferential split was noted at approximately 3.3cm from the proximal end of the distal segment.

• Brand Name: SM ATT PLAS+8FR GROSH+KI
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8896807
• MDR Text Key: 154419185
• Report Number: 3006260740-2019-02402
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025716
• UDI-Public: (01)00801741025716
• Combination Product (y/n): N
• PMA/PMN Number: K873213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0602830
• Device Catalogue Number: 0602830
• Device Lot Number: RECP0272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 12/24/2019
• Supplement Dates FDA Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CHEMOTHERAPY FLUID; CHEMOTHERAPY FLUID
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR