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 7707540CE

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the x-port isp implantable port, groshong single-lumen, kit, 8f that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, kit, 8f are identified.As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, images were provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported that six months and twenty-seven days post port placement using ultrasound guidance via jugular vein approach, the catheter allegedly had a leakage in the neck, exactly before the catheter enters the vein.It was further reported that, after checking the damaged catheter, surgeon noticed catheter allegedly had two small holes.Reportedly, the catheter was removed.The procedure was completed replacing another device.There was no reported patient injury.

Event Description

It was reported that six months and twenty-seven days post port placement using ultrasound guidance via jugular vein approach, the catheter allegedly had a leakage in the neck, exactly before the catheter enters the vein.It was further reported that, after checking the damaged catheter, surgeon noticed catheter allegedly had two small holes.Reportedly, the catheter was removed.The procedure was completed replacing another device.There was no reported patient injury.

Manufacturer Narrative

H10: 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, kit, 8f that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, kit, 8f are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one groshong catheter segment was returned for evaluation.Gross visual, microscopic visual, tactile evaluation and functional testing were performed.In addition to the returned sample, one electronic image was also provided for review.The investigation is confirmed for the reported fluid leak and identified fracture issue as a partial circumferential break was noted and a compound circumferential break was noted on the catheter and the edges were noted to be uneven.Upon infusion, leaks were observed from the breaks on the catheter.However the investigation is inconclusive for the reported material hole issue as there was no hole was noted during the sample evaluation.A definitive root cause could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f - the information provided by bd represents all of 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
• Type of Device: 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: 16360628
• MDR Text Key: 309383469
• Report Number: 3006260740-2023-00419
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K022983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7707540CE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female