MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PPRT MRI ISP 8GR INT; IMPLANTABLE PORT

Model Number 9808560

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was provided, therefore, a lot history review is currently being performed.The device was returned to the manufacturer for evaluation.Therefore, the investigation is identified for the reported leak issue.The definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 9808560 implantable port allegedly experienced subcutaneous leak.This information was received from one source.One patient was involved with no reported patient injury.Age, gender and weight of the patient was not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 9808560 implantable port allegedly experienced subcutaneous leak.This information was received from one source.One patient was involved with no reported patient injury.Age, gender and weight of the patient was not provided.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a lot history review could not be performed.The device was returned to the manufacturer for evaluation.Therefore, the investigation is confirmed for catheter burst and leak.Based upon the available information, the definitive root cause could not be determined.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: PPRT MRI ISP 8GR INT
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10286649
• MDR Text Key: 199266350
• Report Number: 3006260740-2020-02495
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

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: No Information
• Device Model Number: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/19/2020
• Patient Sequence Number: 1