MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. AV SHEATH TUNNELER; SURGICAL TUNNELER

Model Number	AVST2000
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a procedure, the reprocessing instruction outlined with the device was not in compliance with the german law.There was no patient contact.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 09/2024).Device not returned.
Additional Manufacturer Narrative
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 sample was not returned to the manufacturer for evaluation.The instruction for re-sterilization process outlined within the instructions for use does not match exactly the rki guideline recommendations, the instructions provided within the instructions for use has been validated as being capable of preparing the tunneler for surgical use.Per the instructions for use, ¿it remains the responsibility of the processing facility to ensure that processing of the device before use/ reuse using appropriate equipment, materials, and personnel achieves the desired result.This requires verification and/or validation and routine monitoring of the process.Also rki is a set of guidelines.The verbiage within the rki guidelines states ¿recommended¿.Therefore, the investigation is unconfirmed for inadequate instructions for use issue as the provided information within the instruction for use is found to be adequate.A definitive root cause for the alleged inadequate operating instructions 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: 09/2024).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.
Event or Problem Description
It was reported that prior to a procedure, the reprocessing instruction outlined with the device was not in compliance with the german law.There was no patient contact.

• Brand Name: AV SHEATH TUNNELER
• Common Device Name: SURGICAL TUNNELER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12922863
• Report Number: 2020394-2021-02032
• Device Sequence Number: 5696640
• Product Code: KCT
• UDI-Device Identifier: 00801741090530
• UDI-Public: (01)00801741090530
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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: AVST2000
• Device Catalogue Number: AVST2000
• Device Lot Number: VTDW0149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 04/06/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown