MAUDE Adverse Event Report: BARD ACCESS SYSTEMS M.R.I. LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 7F; IMPLANTED PORTS

Catalog Number 0603870C

Device Problem Obstruction of Flow (2423)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Therefore, the reported blocked catheter cannot be confirmed.A definitive root cause could not be determined based upon 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.The catalog number identified has not been cleared in the u.S., but is similar to the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products are identified.

Event Description

It was reported that during the preparation of the port placement, the catheter was allegedly found blocked during the pre-flushing.It was further reported that another device was used to complete the procedure.There was no patient contact.

• Brand Name: M.R.I. LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 7F
• Type of Device: IMPLANTED PORTS
• 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: 10902718
• MDR Text Key: 218245301
• Report Number: 2020394-2020-06441
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111280
• UDI-Public: (01)00801741111280
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K924250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2020

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 Catalogue Number: 0603870C
• Device Lot Number: REDT4436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58 YR
• Patient Weight: 51