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	Difficult to Flush (1251); Fracture (1260); Material Separation (1562); Defective Component (2292); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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
A patient underwent a port placement procedure.During procedure, the port was allegedly found defective.Reportedly, the device was explanted.There was no reported patient injury.
Additional Manufacturer Narrative
H11: 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.D4 (medical device catalog #, medical device lot #, unique identifier (udi) #, medical device expiration date, medical device brand name), g3, h6 (patient, device, component, method).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
A patient underwent a port placement procedure.During procedure, the port was allegedly found defective.Reportedly, the device was explanted.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one power port isp mri implantable port attached to a catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.A split was noted on the attached catheter.The edges of the split on the attached catheter were noted to be uneven.A portion of both split regions were noted to be attached.Upon infusion, a leak was observed from the split on the attached catheter while water exited the distal end.Therefore, the investigation is confirmed for the reported fracture and difficult to flush issues.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, d4 (unique identifier (udi) #), g3, h6 (component, method, result, conclusion).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
A patient underwent a port placement procedure using the powerport m.R.I.Isp.During the procedure, there was resistance with flush.It was found that catheter was allegedly fractured and no contrast material was presented in it.Additionally, the patient experienced pain.The port was removed and replaced.There were no reported patient injuries.
Event or Problem Description
A patient underwent a port placement procedure using the powerport m.R.I.Isp.During the procedure, there was resistance with flush.It was found that that catheter was allegedly fractured and no contrast material was presented in it.Additionally, the patient experienced pain.The port was removed and replaced.There were no reported patient injuries.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: eight electronic photos were provided and reviewed.The photos shows a clinician holding the catheter tube in which a split can be noted on the tube.One power port isp mri implantable port attached to a catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.A split was noted on the attached catheter.The edges of the split on the attached catheter were noted to be uneven.A portion of both split regions were noted to be attached.Upon infusion, a leak was observed from the split on the attached catheter while water exited the distal end.Therefore, the investigation is confirmed for the reported fracture and difficult to flush issues.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (method, result).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.

• 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: 22892090
• Report Number: 3006260740-2025-06222
• Device Sequence Number: 8957613
• 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: AZ
• 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,Followup,Followup
• Report Date (Section B): 12/16/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 10/29/2025; 12/04/2025; 12/16/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/25/2025; 12/09/2025; 12/17/2025
• 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