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

Model Number	EV14
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2022).
Event or Problem Description
It was reported that prior to a biopsy procedure, the package was allegedly found to be damaged.There was no patient contact.
Additional Manufacturer Narrative
H10: additional information was received and the reportability of the file was reassessed and determined to be reportable as malfunction.The initial mdr record was inadvertently submitted with g3 date as (b)(6) 2021.The correct g3 date is (b)(6) 2021.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: one sealed elevation probe was returned for evaluation.The probe showed no damage or evidence of sterile breach to the probe packaging.The received packaging carton of the probe was noted to be damaged.One electronic photo was provided and reviewed.The photo shows the damaged elevation probe's packaging carton.Unit elevation probe can be noted within the damaged carton.Therefore, based on the photo review, the reported packaging problem can be confirmed as it was noted that there was damage in packaging carton.A definitive root cause for the reported device damaged prior to use issue 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: 01/2022), g3,h6(method).H11: h6(device, result and conclusion).
Event or Problem Description
It was reported that prior to a biopsy procedure, the package was allegedly found to be damaged.There was no patient contact.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiry date: 01/2022), g3.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
It was reported that prior to a biopsy procedure, the package was allegedly found to be damaged.There was no patient contact.

• Brand Name: ELEVATION PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11956655
• Report Number: 2020394-2021-01193
• Device Sequence Number: 4420902
• Product Code: KNW
• UDI-Device Identifier: 00801741182396
• UDI-Public: (01)00801741182396
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2021

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: EV14
• Device Catalogue Number: EV14
• Device Lot Number: 91012614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 06/22/2021; 07/16/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/16/2021; 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other