MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HOHN PERCUTANEOUS 7F DUAL-LUMEN CATHETER BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Crack (1135); Material Rupture (1546); Obstruction of Flow (2423)

Patient Problem Tissue Damage (2104)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redp4967 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redp4967) have been reported from the same facility.

Event Description

It was reported that the catheter rupturing external lumen/cracking or upon flushing.No other information was provided.On 7/10/2019: addt'l information rec'd via medwatch: "hohn line found to have one lumen w/ obstruction early morning, concern for clot.Heparin was ordered to clear line.On flushing, minimal pressure was applied by patient nurse w/ subsequent rupture of the external portion of one of the lumens of the line.Ruptured lumen was clamped between the rupture and the patient to ensure no free air entered the line.Entered as patient harm due to patient requiring additional peripheral iv placed w/ need for hohn replacement.Patient w/ no adverse effects otherwise at this time.".

• Brand Name: HOHN PERCUTANEOUS 7F DUAL-LUMEN CATHETER BASIC KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 8786328
• MDR Text Key: 150994884
• Report Number: 3006260740-2019-01946
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036705
• UDI-Public: (01)00801741036705
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/10/2019,07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 6600730
• Device Lot Number: REDP4967
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2019
• Date Manufacturer Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2019
• 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 Age: 27 YR