MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR DRIVER; BIOPSY INSTRUMENT

Model Number	DRENCOR
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the serial number on the inner label did not match with the outer box serial number.There was no patient contact.
Additional Manufacturer Narrative
As the serial number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2045).Device pending return.
Event or Problem Description
It was reported that the serial number on the inner label did not match with the outer box serial number.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record review and manufacturing review was not required as the device was not returned.Investigation summary: the physical device was not returned for evaluation.No photos or video were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the sn discrepancy could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 06/2045), g3.H11: d4 (medical device serial #), e1, g2, h6 (result, 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.H3 other text : device not returned.

• Brand Name: ENCOR DRIVER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12758188
• Report Number: 2020394-2021-01942
• Device Sequence Number: 14516705
• Product Code: KNW
• UDI-Device Identifier: 00801741086076
• UDI-Public: (01)00801741086076
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K040842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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: Health Professional
• Device Model Number: DRENCOR
• Device Catalogue Number: DRENCOR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown