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

Catalog Number	7707540J
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: the catalog number identified in section d4 has not been cleared in the us but is similar to the x-port isp implantable port, groshong single-lumen, 8f products that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, 8f products are identified in d2 and g4.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.H11: 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
It was reported that a catheter placed earlier was found to be ruptured upon removal.The removal was performed on (b)(6) 2018, due to obstruction, and during this process, a catheter fracture was confirmed.There was no reported patient injury.
Additional Manufacturer Narrative
H11: the catalog number identified in section d4 has not been cleared in the us but is similar to the x-port isp implantable port, groshong single-lumen, 8f products that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, 8f products are identified in d2 and g4.Manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one x-port isp implantable port attached to a groshong catheter in two segments was returned for evaluation.Visual, microscopic and functional evaluations were performed on the returned device.The cath-lock was received detached from the port body.Tool damage was noted on the cath-lock.Small splits were noted on the attached catheter.A complete compound break was noted on the distal end of the attached catheter.The distal catheter segment was returned and measured approximately 20.5cm in length.A complete compound break was noted on the proximal end of the distal catheter segment.Slight catheter wear was noted throughout the distal catheter segment.The edges of the complete compound break on the distal end of the attached catheter were noted to be uneven.The surface was noted to be granular throughout.The edges of the complete compound break on the proximal end of the distal catheter segment were noted to be uneven.The surface was noted to be granular throughout.Therefore, the investigation is confirmed for the reported fracture and identified material separation issue.However, the investigation is inconclusive for the reported obstruction of flow issue as the exact circumstances at the time of the reported event cannot be verified from the returned physical sample.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 b5, d6 (medical device explant date), 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.
Event or Problem Description
On (b)(6) 2018, a patient underwent a port placement procedure using the x-port isp implantable port.Post procedure obstruction of flow was identified, a catheter fracture was confirmed.There was no reported patient injury.

• Brand Name: X-PORT ISP 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: 23389495
• Report Number: 3006260740-2025-08018
• Device Sequence Number: 15944947
• Product Code: LJT
• UDI-Device Identifier: 00801741027499
• UDI-Public: (01)00801741027499(17)230228(10)RECQ0002
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2026

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: 02/28/2023
• Device Catalogue Number: 7707540J
• Device Lot Number: RECQ0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2018
• 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