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

Catalog Number	7707540
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978); Naturally Worn (2988)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a port placement procedure using the x-port isp m.R.I.Post the procedure the catheter was allegedly damaged.And subcutaneous leakage from the catheter was confirmed.Additionally, the patient reported pain during catheter infuse.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Section a through f: the information provided 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 x-port isp m.R.I.Post the procedure the catheter was allegedly damaged.And subcutaneous leakage from the catheter was confirmed.Additionally, the patient reported pain during catheter infuse.There was no reported patient injury.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one x-port isp implantable port with an attached groshong catheter were returned for sample evaluation.Gross, visual, microscopic visual, tactile and functional evaluations were performed.A partial compound break was noted on the attached catheter from the distal end of the cath-lock.The edges of the break were noted to be jagged, and surface was noted to be smooth and granular in both regions.Kinks were noted throughout the catheter.Upon infusion, a leak was noted from the partial compound break.Therefore, the investigation is confirmed for the reported leak and identified fracture, wear and deformation issue.However, the investigation is unconfirmed for the reported catheter damage issue as appropriate fracture was identified based on sample evaluation.The definitive root cause could not be determined based upon available information.The identified fracture is typical of flexural fatigue, which is due to the repetitive, cyclic kinking of the catheter.Such kinking may have physiological, placement, usage or mechanical contributing factors.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required b1, b2 (event attributed to), g3, h1, h6 (patient, device, 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.

• Brand Name: X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 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: 23448691
• Report Number: 3006260740-2025-08277
• Device Sequence Number: 21092573
• Product Code: LJT
• UDI-Device Identifier: 00801741027499
• UDI-Public: (01)00801741027499
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7707540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown