MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERHICKMAN 9.5 FR DL INTER. TRAY W SURECUFF; CHRONIC CATHETER

Model Number	0805910
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Of the 2 devices, 1 lot number was provided, and the lot history review was performed.Of the two reported malfunctions, 2 devices and 2 photos were returned for evaluation.The company is still investigating the issue at this time.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.The information reviewed indicated that model 0805910 chronic catheter allegedly experienced catheter dislodgement.These reports were received from various sources.Of the two events, both involved patients with no patient consequences.Age, weight, and gender were not provided for both patients.
Additional Manufacturer Narrative
Of the 2 devices, 1 lot number was provided, and the lot history review was performed.Of the two reported malfunctions, 1 devices and 2 photos were returned for evaluation.Dislodgement of the catheter confirmed for both devices.A definitive root cause could not be detemined.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.The information reviewed indicated that model 0805910 chronic catheter allegedly experienced catheter dislodgement.These reports were received from various sources.Of the two events, both involved patients with no patient consequences.Age, weight, and gender were not provided for both patients.
Event or Problem Description
This report summarizes two malfunctions.The information reviewed indicated that model 0805910 chronic catheter allegedly experienced catheter dislodgement.These reports were received from various sources.Of the two events, both involved patients with no patient consequences.Age, weight, and gender were not provided for both patients.
Additional Manufacturer Narrative
H10: of the 2 devices, 1 lot number was provided, and the lot history review was performed.Of the two reported malfunctions, 2 devices and 2 photos were returned for evaluation.One device was confirmed for dislodgement of the catheter and the second device is currently under investigating the issue at this time.The devices are labeled for single use.H10: g4.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: POWERHICKMAN 9.5 FR DL INTER. TRAY W SURECUFF
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9209552
• Report Number: 3006260740-2019-03161
• Device Sequence Number: 13564710
• Product Code: LJS
• UDI-Device Identifier: 00801741036682
• UDI-Public: (01)00801741036682
• 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): 06/26/2020

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: 0805910
• Device Catalogue Number: 0805910
• Device Lot Number: REDQ0385, UNKNOWN
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 03/24/2020; 06/26/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 03/25/2020; 06/26/2020
• Patient Sequence Number: 1