MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0605510CE

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2022

Event Type  Injury  

Event Description

It was reported that one month and seventeen days post port placement, the device allegedly leaked around the chamber.It was further reported that, upon x-ray the catheter was allegedly fractured.Reportedly, the catheter and port were removed on later days.The current status of the patient is unknown.

Manufacturer Narrative

The catalog number identified in has not been cleared in the us but is similar to the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products are identified in common device name and pma/510k.As the lot number for the device was provided, a review of the device history records will 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 expiry date: 02/2026).The information provide 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.Device not returned.

Event Description

It was reported that one month and seventeen days post port placement, the device allegedly leaked around the chamber.It was further reported that, upon x-ray the catheter was allegedly fractured.Reportedly, the catheter and port were removed on later days.The current status of the patient is unknown.

Manufacturer Narrative

H10: this supplemental mdr is being submitted to report that mfr rpt# 3006260740-2022-03478 was a duplicate record and was opened in error.The event details are being captured under complaint file # (b)(4) and was reported to the fda under mfr rpt# 3006260740-2022-02991.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products are identified in d2 and g4.H10: d4 (expiry date: 02/2026), g3.H11: section a through f ¿ the information provide 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.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 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: 15359561
• MDR Text Key: 299284830
• Report Number: 3006260740-2022-03478
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050310
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0605510CE
• Device Lot Number: REFW3011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• 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
• Patient Outcome(s): Required Intervention