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

Model Number PVT1000

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not 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.

Event Description

It was reported that pv tunneler ifu allegedly was not in compliance with german law.The actual ifu was not matching the actual valid iso-norms regarding cleaning and sterilization.

Manufacturer Narrative

H10: manufacturing review: a lot history review could not be performed as the lot number is unknown.Investigation summary: the physical device was not returned for evaluation.No photos 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 alleged labeling issue could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is not adequate.H10: g3.H11: section a through f: the information provide 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.H3 other text : device not returned.

Event Description

It was reported that pv tunneler ifu allegedly was not in compliance with german law.The actual ifu was not matching the actual valid iso-norms regarding cleaning and sterilization.

• Brand Name: PV SHEATH TUNNELER SET
• Type of Device: SURGICAL TUNNELER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11395184
• MDR Text Key: 234210983
• Report Number: 2020394-2021-00383
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 00801741090257
• UDI-Public: (01)00801741090257
• Combination Product (y/n): N
• PMA/PMN Number: K042062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PVT1000
• Device Catalogue Number: PVT1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other