MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MALLEABLE TUNNELER ACCESSORY

Model Number	5688000
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported malfunction, the device was 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 one (1) malfunction.A review of the reported information indicated that model 5688000 tunneler allegedly experienced the white plastic being crimped.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: for the reported malfunction, the device was returned to bd for evaluation.The investigation is confirmed for a defective device.A root cause has not been determined.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 5688000 tunneler allegedly experienced the white plastic being crumpled.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.

• Brand Name: MALLEABLE TUNNELER ACCESSORY
• Common Device Name: TUNNELER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8822396
• Report Number: 3006260740-2019-02172
• Device Sequence Number: 3206247
• Product Code: MDM
• UDI-Device Identifier: 00801741085475
• UDI-Public: (01)00801741085475
• 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): 10/10/2019

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: 5688000
• Device Catalogue Number: 5688000
• Device Lot Number: RECV3571
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 10/10/2019
• Patient Sequence Number: 1