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
Health Effect - Clinical Code	Tissue Damage (2104)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8786328
• Report Number: 3006260740-2019-01946
• Device Sequence Number: 19294107
• Product Code: LJS
• UDI-Device Identifier: 00801741036705
• UDI-Public: (01)00801741036705
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2019
• Report Date (Section F): 07/10/2019

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR