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); Naturally Worn (2988)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	11/18/2025
Type of Reportable Event	Serious 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 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) 2025, a patient underwent a port placement procedure using the powerport m.R.I.Isp.It was reported that post to the procedure the medication leaked from the catheter and observed swelling under the patient's skin during heparin lock placement.Current status of the patient was unknown.
Event or Problem Description
On (b)(6) 2025, a patient underwent a port placement procedure using the x-port isp m.R.I.It was reported that post to the procedure the medication leaked from the catheter and observed swelling under the patient's skin during heparin lock placement.Current status of the patient was unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one x-port isp implantable port attached to a groshong catheter were returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed.A kink was noted on the proximal portion of the attached catheter.A partial compound break was noted on the attached catheter approximately 5.3cm from the distal end of the cath-lock.The edges of the partial compound break on the attached catheter were noted to be jagged.Both regions were partially attached in the center.The surface was noted to be round/smooth in both regions.Upon infusion, a leak was observed from the partial compound break on the attached catheter.Therefore, the investigation is confirmed for the reported fluid leak and identified catheter fracture, catheter wear and deformation issues.Although a definitive root cause could not be determined, the 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.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, g3, h6 (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: 23775608
• Report Number: 3006260740-2025-09538
• Device Sequence Number: 10131820
• 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): 01/30/2026

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: 12/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/03/2026
• 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