MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MAGNUM REUSABLE CORE BIOPSY INSTRUMENT

Model Number	MN1825
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices for the two malfunctions have been returned to the manufacturer for evaluation; photos of the malfunctions were also received.The investigation of the reported malfunctions are currently underway.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model mn1825 biopsy instrument allegedly experienced difficulty to remove and material twisting.This information was received from various sources.The two malfunctions both involved patients with no reported consequences.The patients were both reported as males; the patients¿ age and weight were not provided.
Additional Manufacturer Narrative
H10: the complaint history reviews were performed and it was determined a device history record review was not required.The devices for the two malfunctions have been returned to the manufacturer for evaluation; photos of the malfunctions were also received.The investigation for both complaints were confirmed for material twisted and bent and were inconclusive for the reported difficult to remove and sampling issue.The definitive root cause could not be determined.The devices are 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 two malfunctions.A review of the reported information indicated that model mn1825 biopsy instrument allegedly experienced difficult to remove and material twisting.This information was received from various sources.The two malfunctions both involved patients with no reported consequences.The patients were both reported as males; the patients¿ age and weight were not provided.

• Brand Name: MAGNUM REUSABLE CORE BIOPSY INSTRUMENT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8813631
• Report Number: 2020394-2019-01711
• Device Sequence Number: 16741691
• Product Code: FCG
• UDI-Device Identifier: 00801741084362
• UDI-Public: (01)00801741084362
• 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): 10/23/2019

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: MN1825
• Device Catalogue Number: MN1825
• Device Lot Number: RECP0981
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/23/2019
• Patient Sequence Number: 1