MAUDE Adverse Event Report: BARD ACCESS SYSTEMS S/L PERC 7FR 65D; CHRONIC CATHETER

Model Number	7711700
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 7711700 s/l perc 7fr 65d experienced a defective component.Of this event, the device was used on the patient with no reported injury.The patient¿s age, sex, and weight were not provided.The 7711700 s/l perc 7fr 65d was returned to the manufacturer and is pending investigation.
Additional Manufacturer Narrative
H10: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged loose cuff as no objective evidence has been provided to confirm any alleged deficiency with the cuff.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.H10: b5, g4 h11: h6 (method 1, conclusion 1) 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 event indicated that model 7711700 chronic catheter allegedly had a defective component.This event did involve patient with no patient consequences.The patient¿s age, sex, and weight were not provided.

• Brand Name: S/L PERC 7FR 65D
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8532730
• Report Number: 3006260740-2019-01069
• Device Sequence Number: 1501767
• Product Code: LJS
• UDI-Device Identifier: 00801741036736
• UDI-Public: (01)00801741036736
• 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): 07/23/2019

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: 7711700
• Device Catalogue Number: 7711700
• Device Lot Number: RECV1476
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1