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

Model Number 9808560

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

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

Event Date 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

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.However, images were provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported that three months and twenty one days post port placement, the catheter was allegedly damaged and leaked saline solution near the port body.It was further reported that two holes were found on the catheter slightly distal to the stem after removal of the port system.Reportedly, the port system was removed from the patient¿s body.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport implantable port attached to a groshong catheter was returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.In addition to the returned physical sample, three medical images were provided for review.The investigation is confirmed for the reported catheter hole and leak issues, as leaks were observed on the groshong catheter in 3 different pinholes, 2 were found near the 15.0cm depth mark and one near the 16.0cm depth mark when hydrostatic pressure was placed on the catheter valve upon infusion.A definitive root cause could not be determined based upon the available 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.

Event Description

It was reported that three months and twenty one days post port placement, the catheter was allegedly damaged and leaked saline solution near the port body.It was further reported that two holes were found on the catheter slightly distal to the stem after removal of the port system.Reportedly, the port system was removed from the patient¿s body.There was no reported patient injury.

Event Description

It was reported that three months and twenty one days post port placement, the catheter was allegedly damaged and leaked saline solution near the port body.It was further reported that two holes were found on the catheter slightly distal to the stem after removal of the port system.Reportedly, the port system was removed from the patient¿s body.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport implantable port attached to a groshong catheter was returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.In addition to the returned physical sample, three medical images were provided for review.The investigation is unconfirmed for the reported catheter hole and leak issues, as no damage was noted on the catheter.An in-house syringe was attached to a safety infusion set and the non-coring needle was inserted into the port septum.The port body was patent to both infusion and aspiration without issue.No leaks were observed.Furthermore, no obvious damage is seen to the port or catheter in the images provided.A definitive root cause could not be determined based upon the available 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: POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 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: 15832807
• MDR Text Key: 307808861
• Report Number: 3006260740-2022-05394
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063377
• 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,Followup
• Report Date: 02/07/2023

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
• Device Operator: Health Professional
• Device Model Number: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 01/11/2023; 02/07/2023
• Supplement Dates FDA Received: 01/13/2023; 02/17/2023
• 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 Age: 52 YR
• Patient Sex: Female
• Patient Weight: 37 KG