MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN D/L CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	0600620
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, lot number was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0600620 chronic catheter allegedly experienced failure to bond.This report was received from a single source.This event did involve patient with no patient injury.Age, weight, and gender were not provided for the patient.
Additional Manufacturer Narrative
As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.Therefore, the investigation is confirmed for the reported loss of or failure to bond.Based upon the available information, the definitive root cause for this event is unknown.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0600620 chronic catheter allegedly experienced failure to bond.This report was received from a single source.This event did involve patient with no patient injury.Age, weight, and gender were not provided for the patient.
Additional Manufacturer Narrative
For the reported event, lot number was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device was 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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0600620 chronic catheter allegedly experienced failure to bond.This report was received from a single source.This event did involve patient with no patient injury.Age, weight, and gender were not provided for the patient.

• Brand Name: HICKMAN D/L CATHETERS
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; lot #1, road #3, km 79.7; salt lake city UT 84116
• MDR Report Key: 9950864
• Report Number: 3006260740-2020-01241
• Device Sequence Number: 19651267
• Product Code: LJS
• UDI-Device Identifier: 00801741051913
• UDI-Public: (01)00801741051913
• 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,Followup
• Report Date (Section B): 10/21/2020

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: 0600620
• Device Catalogue Number: 0600620
• Device Lot Number: HUDP0527
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 03/31/2020; 09/30/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 04/14/2020; 10/21/2020
• Patient Sequence Number: 1