MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARDPORT LOW-PROFILE DUAL-LUMEN IMPLANTABLE PORT WITH ATTACHABLE 7F OPEN-ENDED; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0604970
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the patient¿s dual port would not aspirate or infuse.During the patient¿s chemotherapy treatment only one port worked and he had to have an iv placed for fluids.Approximately one week ago both ports stopped working and the patient had to have chemotherapy through his iv.The port was removed.There was no reported patient injury.
Additional Manufacturer Narrative
The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Received was one dual slimport with detached 7f dual lumen catheter and cath-lock.The catheter and port displayed signs of use.The port stem is damaged and one end of the catheter also appears to be damaged, but the cause of these damaged areas is not clear.As the reported details include manipulation after explant, it cannot be determined whether the damage observed is connected to the alleged issue or another source of damage.Therefore, the investigation is inconclusive for inability to aspirate or infuse.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.A review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate.(expiry date: 04/2022).(b)(4).
Event or Problem Description
It was reported that the patient¿s dual port would not aspirate or infuse.During the patient¿s chemotherapy treatment only one port worked and he had to have an iv placed for fluids.Approximately one week ago both ports stopped working and the patient had to have chemotherapy through his iv.The port was removed.There was no reported patient injury.

• Brand Name: BARDPORT LOW-PROFILE DUAL-LUMEN IMPLANTABLE PORT WITH ATTACHABLE 7F OPEN-ENDED
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7879531
• Report Number: 3006260740-2018-02491
• Device Sequence Number: 2218272
• Product Code: LJT
• UDI-Device Identifier: 00801741025884
• UDI-Public: (01)00801741025884
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K964066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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
• Operator of Device: Health Professional
• Device Model Number: 0604970
• Device Catalogue Number: 0604970
• Device Lot Number: REBR0916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 64