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	0600730
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the doctor managed to gain access to a vein with a needle but was unable to push the guidewire through.Reportedly the guidewire was just not able to go through the vein and kinked.The doctor had to opened a new guidewire and then was able to complete the procedure successfully.
Additional Manufacturer Narrative
The initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred.The information provided does not reasonably suggest the event may have caused or contributed to a death or serious injury of a patient, user or other person.If this event were to recur, it does not pose an incremental risk of harm to the patient, user, or other person.Therefore this event is deemed not reportable per 21 cfr part 803.
Event or Problem Description
It was reported that the doctor managed to gain access to a vein with a needle but was unable to push the guidewire through.Reportedly the guidewire was just not able to go through the vein and kinked.The doctor had to opened a new guidewire and then was able to complete the procedure successfully.

• 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: 7813921
• Report Number: 3006260740-2018-02228
• Device Sequence Number: 1290940
• Product Code: LJS
• UDI-Device Identifier: 00801741074462
• UDI-Public: (01)00801741074462
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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: 0600730
• Device Catalogue Number: 0600730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1