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

Model Number 1716000

Device Problems Fluid/Blood Leak (1250); Suction Problem (2170); Material Protrusion/Extrusion (2979)

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

Event Date 07/28/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation as well as a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 08/2023).

Event Description

It was reported that two months and twelve days post port placement, the septum had allegedly dislodged from the port body.It was further reported that the port allegedly leaked and the port was unable to be aspirated.Reportedly the port was removed.There was no reported patient injury.

Event Description

It was reported that two months and twelve days post port placement, the septum had allegedly dislodged from the port body.It was further reported that the port allegedly leaked and the port was unable to be aspirated.Reportedly the port was removed.There was no reported patient injury.

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 powerport slim mri implantable port attached to a catheter was returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.A complete circumferential break was noted on the distal end of the catheter attached.However, striations were noted throughout the surface.Although the sample was returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for the reported material protrusion, fluid leak and suction issues, as the port septum was noted to be dislodged from the port body.A leak from the port septum was noted upon infusion.Aspiration was attempted but was unsuccessful.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 (expiration date: 08/2023).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.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 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: 15264193
• MDR Text Key: 305065687
• Report Number: 3006260740-2022-03259
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026744
• UDI-Public: (01)00801741026744
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1716000
• Device Catalogue Number: 1716000
• Device Lot Number: REFZ1362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• 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 Age: 75 YR
• Patient Sex: Female