MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 INTL POWERPORT TI, 8FR, CHRONOFLEX INT WSP, ATT, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8708000

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem Swelling/ Edema (4577)

Event Date 02/18/2021

Event Type  Injury  

Manufacturer Narrative

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.The catalog number identified has not been cleared in the us but is similar to the powerport implanted titanium port w/8 fr.Chronoflex catheter products that are cleared in the us.The pro code and 510 k number for the powerport implanted titanium port w/8 fr.Chronoflex catheter products are identified.(expiry date: 06/2022).

Event Description

It was reported that post port placement, the device allegedly leaked and detached from the port stem.The patient allegedly experienced swelling around the port site.The patient's current status was unknown.

Manufacturer Narrative

The catalog number identified in section has not been cleared in the us but is similar to the powerport implanted titanium port w/8 fr.Chronoflex catheter products that are cleared in the us.The pro code and 510k number for the powerport implanted titanium port w/8 fr.Chronoflex catheter products are identified.This is the first complaint reported to date for this product and lot, therefore a device history record review is not required.The device was not returned for evaluation.Therefore, the investigation is inconclusive for the reported catheter detachment and leak issue.A definitive root cause could not be determined based upon the available information.A review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 06/2022).

Event Description

It was reported that post port placement, the device allegedly leaked and disconnected from the port stem.The patient allegedly experienced swelling around the port site.Reportedly, the device was removed on later days.The procedure was completed using another device.The patient's current status was unknown.

• Brand Name: INTL POWERPORT TI, 8FR, CHRONOFLEX INT WSP, ATT, SL
• 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: 11655728
• MDR Text Key: 245107724
• Report Number: 3006260740-2021-01291
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K060812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8708000
• Device Lot Number: REEV2611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2021
• 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): Other