MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN S/L CATHETERS; CHRONIC CATHETER

Model Number	0600524
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the two reported malfunctions, one lot number was provided and a lot history review was performed.The device for one malfunction was returned for evaluation and the investigation confirmed for material deformation.The definitive root cause is unknown.The return of the other device is pending.The company is investigating the issue at this time.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model 0600524 chronic catheter allegedly experienced material deformation.This information was received from various sources.Both malfunctions involved a patient with no reported patient injury.Patient information was not provided.
Additional Manufacturer Narrative
H10: for the two reported malfunctions, one lot number was provided and a lot history review was performed.The devices for both malfunctions were returned for evaluation and the investigation confirmed for material deformation.The definitive root cause is unknown.The devices are labeled for singe use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model 0600524 chronic catheter allegedly experienced material deformation.This information was received from various sources.Both malfunctions involved a patient with no reported patient injury.Patient information was not provided.

• Brand Name: HICKMAN S/L CATHETERS
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9203841
• Report Number: 3006260740-2019-03084
• Device Sequence Number: 2950457
• Product Code: LJS
• UDI-Device Identifier: 00801741051814
• UDI-Public: (01)00801741051814
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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
• Operator of Device: No Information
• Device Model Number: 0600524
• Device Catalogue Number: 0600524
• Device Lot Number: HUBV0714, UNKNOWN
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 01/07/2020
• Patient Sequence Number: 1