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

Model Number	ECP017GV
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of two for this event.As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2022).
Event or Problem Description
It was reported that prior to a biopsy procedure, the probe packaging was allegedly damaged.There was no patient contact.
Event or Problem Description
It was reported that prior to a biopsy procedure, the probe packaging was allegedly damaged.There was no patient contact.
Additional Manufacturer Narrative
H10: as this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of two for this event.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.Three electronic photos were provided for review.The first photo confirms the lot number and catalog number of the product.Second and third photo was observed that the crack was found and visible in two photos.Therefore, the investigation is confirmed for the reported tear, rip or hole in device packaging (crack and sterile breach on package).A definitive root cause for the alleged tear, rip or hole in device packaging 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: 03/2022), g3, h6 (method).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.

• Brand Name: ENCOR PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12426172
• Report Number: 2020394-2021-01575
• Device Sequence Number: 3332694
• Product Code: KNW
• UDI-Device Identifier: 00801741086298
• UDI-Public: (01)00801741086298
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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: Health Professional
• Device Model Number: ECP017GV
• Device Catalogue Number: ECP017GV
• Device Lot Number: VTEQ0182
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/04/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1