MAUDE Adverse Event Report: BARD ACCESS SYSTEMS M.R.I. IMPLANTABLE PORT

Model Number 0602680

Device Problems Fracture (1260); Material Protrusion/Extrusion (2979)

Patient Problem Injury (2348)

Event Date 03/16/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the lot number was provided and a device history records (dhr) review was performed.The lot met all release criteria.Dhr was reviewed and no deviations/issues were identified or associated with this problem in regards to product materials or during manufacturing, packaging or qc inspection process.All necessary inspections were performed throughout all manufacturing, packaging and inspection activities and for (b)(4) material utilized in the manufacture of this lot in regards to the described problem.Investigation summary: the sample was not returned for evaluation.Four electronics photos were provided for review.The investigation is inconclusive for port septum fracture and device occlusion, as the photo review did not identify any fractures or occlusions.However, the investigation is confirmed for dislodged port septum, as the photo review identified a port septum that appeared to be rotated in the port body.A portion of the bottom septum bolster was visible in the photos.A definitive root cause could not be determined.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.Medical device - expiry date: 08/2023.

Event Description

It was reported that the patient allegedly had a catheter implanted for less than one month and was unable to receive chemotherapy.Reportedly, the physician requested the device be replaced claiming it was obstructed.The device was removed and replaced.Upon removal of the device, it was identified that there was a rupture of silicone.The current patient status is unknown.

• Brand Name: M.R.I. IMPLANTABLE PORT
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10442451
• MDR Text Key: 204028927
• Report Number: 3006260740-2020-03027
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025679
• UDI-Public: (01)00801741025679
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K873213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0602680
• Device Catalogue Number: 0602680
• Device Lot Number: REDT0856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2019
• 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 Outcome(s): Hospitalization
• Patient Age: 45 YR