MAUDE Adverse Event Report: BARD ACCESS SYSTEMS S/L PERC 8FR 65D; CHRONIC CATHETER

Model Number	7711800
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided, a manufacturing review was performed.The devices were returned to bd and are pending evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 7711800 chronic catheter allegedly broke.This information was received from one source.This malfunction involved patient with no known impact to the patient.The patient was (b)(6) male and weighed (b)(6).
Additional Manufacturer Narrative
H10: the lot number for the device was provided, therefore, a lot history review was performed.The device was returned to bd and the investigation is confirmed for catheter break and material separation.A root cause has not been determined.The device was labeled for single use.H10: g4.H11: h6 (device, results, conclusion).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 7711800 chronic catheter allegedly broke.This information was received from one source.This malfunction involved patient with no known impact to the patient.The patient was 56-years old male and weighed 327 lbs.

• Brand Name: S/L PERC 8FR 65D
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10283927
• Report Number: 3006260740-2020-02467
• Device Sequence Number: 2679690
• Product Code: LJS
• UDI-Device Identifier: 00801741036743
• UDI-Public: (01)00801741036743
• 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): 10/13/2020

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: 7711800
• Device Catalogue Number: 7711800
• Device Lot Number: REDW1403
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 10/13/2020
• Patient Sequence Number: 1