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 Fracture (1260); Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)

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

Event Date 06/10/2022

Event Type  malfunction  

Event Description

It was reported that during a port placement procedure, the sheath was allegedly bent and the catheter could not be inserted.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport mri isp implantable port, one flushing connector and a cath-lock loaded to a groshong catheter, one vein pick, one cath-lock, one right-angle non-coring needle, one straight non-coring needle, one vessel dilator, one groshong catheter segment and one 8.0fr partially peeled peel-apart sheath and vessel dilator were returned for evaluation.Gross visual, microscopic visual, tactile evaluation and functional testing were performed.However, the investigation is inconclusive for the reported difficult to insert issue as the exact circumstances at the time of the reported event cannot be verified and the sample evaluation results indicating no difficulty under laboratory conditions are not by themselves sufficient to confirm this event occurred under clinical conditions.The investigation is confirmed for the reported sheath deformation and identified fracture issues as the 8.0fr sheath was noted to have a complete diagonal break and was noted to be bent.Further, a kink was noted on the sheath and the vessel dilator was noted to be bent.Under microscopic observation, the edges of the complete diagonal break on the peel-apart sheath was noted to be uneven.A definitive root cause could not be determined based on 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.(expiration date: 04/2024).

• 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: 15501633
• MDR Text Key: 306251990
• Report Number: 3006260740-2022-03794
• 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
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• 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: REFY2035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• 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