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

Model Number	7711700
Medical Device Problem Codes	Fracture (1260); Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, the device was returned to bd and evaluated.The photo review is currently underway review.The company is still investigating the issue at this time.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 7711700 chronic catheter was allegedly experienced material frayed.This report was received from a single source.This event did involve patient with no reported patient injury.Age, weight, and gender were not provided for the patient.
Additional Manufacturer Narrative
H10: the lot number was provided; therefore, a lot history review will be performed.The sample was returned and evaluated.The photo review is currently underway.The company is still investigating the issue at this time.The device was labeled for single use.H10: g4 h11: g1 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 7711700 chronic catheter was allegedly experienced material frayed.This report was received from a single source.This event did involve patient with no reported patient injury.Age, weight, and gender were not provided for the patient.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The sample and photo were returned and evaluated.The investigation was confirmed for the alleged fraying of the guidewire as well as the breaking of the core wire.Based upon the available information, the definitive root cause for this malfunction was unknown.The device was labeled for single use.H10: g4 h11: b5, h6 (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 7711700 chronic catheter allegedly experienced material frayed.This report was received from a single source.This malfunction did involve patient with no reported patient injury.Age, weight and gender were not provided for the patient.

• 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: 9970037
• Report Number: 3006260740-2020-01357
• Device Sequence Number: 14541994
• 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,Followup
• Report Date (Section B): 10/12/2020

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: 7711700
• Device Catalogue Number: 7711700
• Device Lot Number: REDN2497
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/29/2020; 09/30/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 07/09/2020; 10/12/2020
• Patient Sequence Number: 1