MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 VACCESS CT POWER-INJECTABLE IMPLANTABLE PORT, CHRONOFLEX, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 7480000

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 07/06/2022

Event Type  malfunction  

Event Description

It was reported that sometime post port placement, it was confirmed in magnetic resonance imaging that the port had allegedly moved.It was further reported that the port allegedly had shifted a little as it was not accessed in the same spot but would typically accessed it with the needle.Furthermore, the patient allegedly noticed some pain and tugging sensation.However, there is no information provided regarding intervention or medication to treat pain and tugging sensation.There was no reported patient injury.

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.

Event Description

It was reported that ten months and four days post port placement, it was confirmed in magnetic resonance imaging that the port had allegedly moved.It was further reported that the port allegedly had shifted a little as it was not accessed in the same spot but would typically accessed it with the needle.Furthermore, the patient allegedly noticed some pain and tugging sensation.However, there is no information provided regarding intervention or medication to treat pain and tugging sensation.There was no reported patient injury.

Manufacturer Narrative

H10: additional information was received, there was no problem with the port and the port is working as intended.Hence this record will not be considered as a complaint.However, since an initial mdr was submitted, the file will remain assessed as a malfunction.H10: d4 (expiry date: 04/2023).H11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device not returned.

• Brand Name: VACCESS CT POWER-INJECTABLE IMPLANTABLE PORT, CHRONOFLEX, 6F
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16562764
• MDR Text Key: 311506650
• Report Number: 3006260740-2023-00871
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027475
• UDI-Public: (01)00801741027475
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

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: 7480000
• Device Catalogue Number: 7480000
• Device Lot Number: REFT1530
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 04/18/2023
• 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
• Patient Sex: Female