MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN CV CATHETER, SINGLE-LUMEN, 9.6F; CHRONIC CATHETER

Model Number	0600160
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided for 1 out of 2 malfunctions; therefore, a lot history review was performed.The devices for both malfunctions were returned for evaluation.For 2 malfunctions, the investigation is identified a cuff detachment during evaluation.Based on the available information, the definitive root cause is unknown.The device are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model 0600160 chronic catheter allegedly experienced cuff detachment.These reports were received from various sources.All two malfunctions involved a patient with no reported patient consequences.The patient's age, weight and gender were not provided.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model 0600160 chronic catheter allegedly experienced cuff detachment and material split.These reports were received from various sources.All two malfunctions involved a patient with no reported patient consequences.The patient's age, weight and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for 1 out of 2 malfunctions; therefore, a lot history review was performed.The devices for both malfunctions were returned for evaluation.For one malfunction, investigation is confirmed for cuff detachment.For another malfunction, the investigation is confirmed for the identified split and unconfirmed for the reported cuff detachment.Based on the available information, the definitive root cause is unknown.The device are labeled for single use.H11:section a through f: the information provided by bd 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 bd.

• Brand Name: HICKMAN CV CATHETER, SINGLE-LUMEN, 9.6F
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10750222
• Report Number: 3006260740-2020-03544
• Device Sequence Number: 13872907
• Product Code: LJS
• UDI-Device Identifier: 00801741051722
• UDI-Public: (01)00801741051722
• 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): 01/07/2021

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: 0600160
• Device Catalogue Number: 0600160
• Device Lot Number: HUDX2521, UNKNOWN
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 01/07/2021
• Patient Sequence Number: 1