MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SM ATT PLAS 8FR GROSH KIT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0602833

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was not provided, therefore, the device history records could not be performed.The return of the device is pending.The investigation is currently underway.

Event Description

It was reported that when using the port, an abnormality was seen, and as a result of examination, the catheter alleged fracture was found out.There was no reported patient injury.It was also reported that the distal catheter segment and the port body were removed.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: received one plastic port with 8fr groshong catheter is two pieces.Visual inspection identified a complete circumferential break, two partial circumferential splits, and one hole to the catheter.The circumferential break is characterized by a rough end with a portion of smoothing.The more proximal of the two splits is characterized by smooth edges, and the more distal of the two splits is characterized by granular edges.The identified hole is characterized by uneven sides with no distinctive edge characteristics.Therefore, based on the break the investigation is confirmed for a subcutaneous leak/break/split without embolism.The complete break and the proximal circumferential split were characterized by smooth surfaces, which is consistent with flexural fatigue; however, the definitive root cause could not be determined for any of the identified failures based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported that when using the port, an abnormality was seen, and as a result of examination, the catheter alleged fracture was found out.There was no reported patient injury.It was also reported that the distal catheter segment and the port body were removed.There was no reported patient injury.

• Brand Name: SM ATT PLAS 8FR GROSH KIT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8199078
• MDR Text Key: 131491858
• Report Number: 3006260740-2018-03743
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025723
• UDI-Public: (01)00801741025723
• Combination Product (y/n): N
• PMA/PMN Number: K873213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

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 Model Number: 0602833
• Device Catalogue Number: 0602833
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 03/15/2019
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1