MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERHICKMAN 8 FR SL; CHRONIC CATHETER

Model Number	0802815
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported malfunction, three devices and a photo were returned to bd for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model 0802815 chronic catheter allegedly experienced a missing component.This information was received from one source.The malfunctions involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number for this malfunction was provided and a lot history review was performed.For the reported malfunction, the device and photo has been returned for evaluation.The evaluation is inconclusive for missing component.Based upon the available information, a definitive root cause is unknown.The device is 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 0802815 chronic catheter allegedly experienced a missing component.This information was received from one source.The malfunctions involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.

• Brand Name: POWERHICKMAN 8 FR SL
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9598168
• Report Number: 3006260740-2020-00157
• Device Sequence Number: 3174891
• Product Code: LJS
• UDI-Device Identifier: 00801741036644
• UDI-Public: (01)00801741036644(17)200930
• 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): 04/03/2020

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: 0802815
• Device Catalogue Number: 0802815
• Device Lot Number: RECX0482
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 04/03/2020
• Patient Sequence Number: 1