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

Catalog Number	4808560
Medical Device Problem Codes	Nonstandard Device (1420); Fitting Problem (2183); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one power port mri isp implantable port was return for sample evaluations.Visual, microscopic visual, dimensional and functional evaluations were performed.The port stem appears to be slightly detached from the port body and gap, was found between the port stem and the port body.The port was patent to both infusion and aspiration.As per additional evaluations and split was carefully made on the port stem area of the port body for further inspection.Upon finalizing the split, it was noted that the port stem was not fully seating withing the port stem chamber area.No significant gashes or gouges were noted within the port stem chamber surface.The transverse ring (proximal stem barb) surface was noted to be depressed.Manufacturing review was performed and ¿stem slightly separated from port¿ was confirmed.A closer view showed puncture accesses through the septum of the port; it was observed that the stem of the port was slightly separated from the base.Ct scan was performed, and the stem and port are within specification.All the investigation indicates that the stem was not likely ever fully inserted during assembly and failed attached to the catheter.Therefore, the investigation is confirmed for the reported fitting problem and identified component miss assembled issue.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.The root cause was determined to be manufacturing related issue.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required section a through f ¿ the information provide by bd represents all 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 or Problem Description
On (b)(6) 2024, a patient was prepped for port placement procedure using the mri powerport isp.Prior to port placement, the catheter allegedly could not attach to the port.Further it was found that there was a fitting and component misassembled issues.There was no patient contact.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• Common Device Name: 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: 22607499
• Report Number: 3006260740-2025-05201
• Device Sequence Number: 18542625
• Product Code: LJT
• UDI-Device Identifier: 00801741027345
• UDI-Public: (01)00801741027345(11)230517(17)250731(10)REHQ1616
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: 4808560
• Device Lot Number: REHQ1616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown