MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM IMPLANTABLE PORT SINGLE-LUMEN PERITONEAL CATHETER; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0603006

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Device not returned.

Event Description

It was reported that some time post port placement, the cath-lock over sleeve allegedly disconnected.It was further reported that intraperitoneal administration had been completed when the cath-lock over sleeve was found to have disconnected.Reportedly, due to the shift to palliative medicine, the port system and the cath-lock over sleeve were not removed.The device remained in the patient and shifted to palliative care.There was no reported patient injury.

• Brand Name: TITANIUM IMPLANTABLE PORT SINGLE-LUMEN PERITONEAL CATHETER
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13540111
• MDR Text Key: 285683018
• Report Number: 3006260740-2022-00334
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025792
• UDI-Public: (01)00801741025792
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K870260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0603006
• Device Catalogue Number: 0603006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1