MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. MONOPTY; BIOPSY INSTRUMENT

Model Number	121410
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For one of the *two* malfunctions, the devices were returned to bd and is pending evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes two malfunction.A review of the reported information indicated that model 121410 monopty allegedly experienced self activation.This information was received from various sources.This malfunction does not involved two patients.The patient's age, weight and gender were not provided.
Additional Manufacturer Narrative
H10: of the reported 2 devices, lot numbers were provide for all the devices, and the lot history reviews were performed.Of the 2 reported malfunctions, one device returned to the manufacturer for evaluation and one device is not returned.Therefore, the investigation of the reported event is inconclusive for one malfunction.Additionally one malfunction was confirmed the reported self-activation.Based on the available information, the definitive root cause for this event is unknown.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 malfunction.A review of the reported information indicated that model 121410 monopty allegedly experienced self activation.This information was received from various sources.This malfunction does not involved two patients.The patient's age, weight and gender were not provided.

• Brand Name: MONOPTY
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• MDR Report Key: 10750241
• Report Number: 2020394-2020-06186
• Device Sequence Number: 3140677
• Product Code: KNW
• UDI-Device Identifier: 00801741084584
• UDI-Public: (01)00801741084584
• 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): 01/06/2021

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: 121410
• Device Catalogue Number: 121410
• Device Lot Number: REDQ4105, REEP1808
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 01/06/2021
• Patient Sequence Number: 1