MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8808560

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Suction Problem (2170); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)

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

Event Date 08/07/2022

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.The investigation of the reported event is currently underway.Expiry date: 05/2021.

Event Description

It was reported approximately two years and six months post port placement procedure, the device allegedly had suction issue.It was further reported that the device was ruptured in the tubing in the right supraclavicular region.Reportedly, the small amount of extravasation was confirmed.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport mri implantable port attached to a groshong catheter was returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.The investigation is confirmed for the reported fracture and leak issues and the identified deformation and worn issues, as two partial circumferential breaks were noted approximately 6.0cm and 6.9cm from the distal end of the cath-lock.The surface of the first partial circumferential break on the attached catheter was noted to be granular and glossy.The surface of the second partial circumferential break on the attached catheter was noted to be granular and glossy.Upon infusion, leaks from the partial circumferential breaks were observed.However, the investigation is inconclusive for the reported suction issue, as the exact circumstances at the time of the reported event cannot be verified, and the reported event could not be reproduced in the lab.The identified break is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.The definitive root cause could not be determined based upon 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: 05/2021), g3, h6 (device, method).H11: b3, b5, h6 (result, conclusion).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.

Event Description

It was reported two years and four months post port placement procedure, the device allegedly had suction issue.It was further reported that the device was ruptured in the tubing in the right supraclavicular region.Reportedly, the small amount of extravasation was confirmed.There was no reported patient injury.

• Brand Name: POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15493316
• MDR Text Key: 305895204
• Report Number: 3006260740-2022-03762
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098994
• UDI-Public: (01)00801741098994
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063377
• 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: 11/09/2022

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 Catalogue Number: 8808560
• Device Lot Number: REDT1949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 11/09/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2019
• 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