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

Catalog Number DRENCOR

Device Problems Accessory Incompatible (1004); Contamination (1120); Mechanical Problem (1384); Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2023

Event Type  malfunction  

Event Description

It was reported that post a biopsy procedure, the driver was allegedly contaminated with fluid in the gears.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a dhr and manufacturing review was not required as the event was determined to be expected and the investigation did not identify any manufacturing and/or service-related issues.Investigation summary: the encor driver serial number (b)(6) was received at the bd-bard global service & repair.The encor driver was visually inspected upon receipt and was found to be in good overall condition and does not function.Also, found that both latch strikes and both distal caches were discolored.Blood was found in the crevices of the device and the sensor cover was contaminated and discolored.The device was functionally tested and failed to initialize due to a ¿button stuck¿ error identified during evaluation.Furthermore, the device was flooded with blood internally.The device would unexpectedly start during motor power test and the readings were able to be taken, but not without the device starting and stopping unexpectedly.The front cb failed with pd1 continuously illuminating during the test.No other anomalies were identified.Three photos were provided by the customer.The first photo, show that the encor driver and contamination was noted on the gear portion of the driver.Second photo shows that the product information and serial number.The serial number matches the trackwise serial number (b)(6).Third photo shows that the device complaint sheet.No other visual anomalies were noted.Based on the photo review, the reported contaminated issue is confirmed.Therefore, the investigation is determined to be confirmed for the reported device was contaminated with fluid in the gears and the investigation is determined to be confirmed for identified failed to initialize and the investigation is determined to be confirmed for the identified pd1 continuously illuminating issue and the investigation is determined to be confirmed for identified unexpectedly start motor issue.Based on the returned sample evaluation and photo review the root cause for reported device was contaminated with fluid in the gears issue is unknown.Based on the returned sample evaluation, the root cause for identified failed to initialize issue was determined to be ¿button stuck¿ error identified during evaluation.Also, identified device was the device was flooded with blood internally is likely to contribute to the identified failed to initialize.The root cause for the pd1 continuously illuminating issue is unknown.The root cause for the identified unexpectedly start motor issue is unknown.Labeling review: the labeling/packaging review was not required as the reported event is not associated with a labeling, packaging, or use related issue.H10: d4 (expiration date: 06/2045).H11: section a through f ¿ the information provided by bd represents all 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.

• Brand Name: ENCOR DRIVER
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18396467
• MDR Text Key: 331371074
• Report Number: 2020394-2023-01323
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741086076
• UDI-Public: (01)00801741086076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DRENCOR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1