MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER PORT ISP M.R.I., 8FR GROSHONG; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 4808570J

Device Problems Fracture (1260); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the power port isp m.R.I., 8fr groshong that are cleared in the us.The pro code and 510 k number for the power port isp m.R.I., 8fr groshong are identified in d2 and g4.H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.

Event Description

It was reported that approximately two years post port placement procedure, the catheter allegedly had a break.Reportedly, the port was removed and replaced.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the power port isp m.R.I., 8fr groshong that are cleared in the us.The pro code and 510 k number for the power port isp m.R.I., 8fr groshong are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport implantable port attached to a groshong catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.Two partial circumferential break was noted from the cath-lock and also a split was noted.The edges of the partial circumferential breaks on the attached catheter were noted to be uneven and the surfaces were noted to be round and smooth on both regions.Therefore the investigation is confirmed for the reported fracture and the identified naturally worn and deformation issues.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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.

Event Description

It was reported that approximately two years post port placement procedure, the catheter allegedly had a break.Reportedly, the port was removed and replaced.There was no reported patient injury.

• Brand Name: POWER PORT ISP M.R.I., 8FR GROSHONG
• 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: 18418474
• MDR Text Key: 331601428
• Report Number: 3006260740-2023-05934
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741175725
• UDI-Public: (01)00801741175725
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/05/2024

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: 4808570J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/08/2024
• 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