MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VENAFLO VASCULAR GRAFT; EPTFE VASCULAR GRAFT

Catalog Number VLT4547C

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

Medical records were not provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.A medical image was made available and a review is currently being under way.The device is available for evaluation and a sample return kit was sent to the facility and is pending return.The results of the device evaluation will be furnished upon completion of the event investigation which is currently underway.The information provided by bard 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 bard.

Event Description

It was reported that upon receipt, the vascular graft was allegedly identified to be dirty; rendering the device unusable.There was no reported patient involvement.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Visual inspection: the sample was not returned; therefore, visual inspection could not be performed.Functional/performance evaluation: the sample was not returned; therefore, functional/performance evaluation could not be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: two digital photos were reviewed.The first photo showed the front label of the eptfe vascular graft.Some apparent contaminates were identified across the label.The second photo showed what appeared to be the back of the box for the eptfe vascular graft.Contaminates were identified along the transition between the back label and box material.Based on the photos it was confirmed that contaminates were on the outer packaging of the device.The box appeared to be sealed and no contaminates were identified on the graft itself.Conclusion: the device was not returned however, photos were provided.The investigation was confirmed for item contamination of the outer packaging during manufacturing or shipping.The investigation was unconfirmed for foreign material on the graft as the photos showed a still sealed box, and it was confirmed the complaint was on the outer packaging only.The contamination that was located on the outer packaging would not effect the integrity of sterilization of the graft contained in the inner packaging.No foreign material was introduced to the graft as it remained sealed in the inner packaging tray.The outer packaging contamination could have been caused by the shipping of the device or the handling of the device prior to use.However, the definitive root cause was unknown.Labeling review: the current instruction for use (ifu) states: warnings: all venaflo ii eptfe vascular grafts are supplied sterile and non-pyrogenic unless the package is open or damaged.Venaflo eptfe vascular grafts are sterilized by ethylene oxide.Opening the package: hold the outer tray in one hand.Peel back the lid, remove the inner tray.Peel back the inner tray lid slowly and carefully remove the graft using sterile atraumatic instruments or sterile gloves.The information provided by bard 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 bard.

Event Description

It was reported that upon receipt, the vascular graft was allegedly identified to be dirty; rendering the device unusable.There was no reported patient involvement.

• Brand Name: VENAFLO VASCULAR GRAFT
• Type of Device: EPTFE VASCULAR GRAFT
• 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: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5881161
• MDR Text Key: 52276044
• Report Number: 2020394-2016-00776
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741020612
• UDI-Public: (01)00801741020612(17)210214(10)VTAP0492
• Combination Product (y/n): N
• PMA/PMN Number: K052282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/14/2021
• Device Catalogue Number: VLT4547C
• Device Lot Number: VTAP0492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1