MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP TI 8F CHRONWSH; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8708060

Device Problems Partial Blockage (1065); Fluid/Blood Leak (1250); Reflux within Device (1522); Obstruction of Flow (2423)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record 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 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: 10/2021.

Event Description

It was reported that post port placement, the catheter was allegedly obstructed in the distal end and leaked.The current status of the patient is unknown.

Event Description

It was reported that post port placement, the catheter was allegedly partially blocked in the distal end and abnormal contrast reflux.The current status of the patient was unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ti power port isp attached to a catheter.Gross visual, microscopic, functional and tactile evaluation were performed on the returned device.The investigation is inconclusive for the reported obstruction of flow and reflux within device as the exact circumstances during the reported event were unknown.During functional evaluation upon infusion, resistance was met and a clear residue exited the distal end of the catheter.Therefore, the investigation is confirmed for the reported partial blockage.However, the investigation is inconclusive for the reported reflux within device as the exact circumstances at the time of the reported event are unknown and the issue was not identified during sample evaluation.A definitive root cause could not be determined based upon the available information.Labeling review: 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.H10: d4 (expiry date: 10/2021).H11:section a through f - the information provided by bd 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 bd.H3 other text : see h10.

• Brand Name: POWERPORT ISP TI 8F CHRONWSH
• 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: 12244575
• MDR Text Key: 264035400
• Report Number: 3006260740-2021-02984
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K072215
• 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,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8708060
• Device Lot Number: REEV2612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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