MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM; VENA CAVA FILTER

Catalog Number DL900F

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.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 the inner packaging pouch was allegedly open as it was removed from the box.There was no reported patient involvement.

Manufacturer Narrative

Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.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 event reported to date for this lot number and failure mode.Visual inspection: the outer carton was returned bent within a large cardboard box.The outer packaging sleeve, containing both inner packaging sleeves, was also bent to fit within the cardboard box.When removed the outer carton appeared to be flattened in some areas.Per the reported details, the outer carton had noted damage when it was received by the facility.When the outer sleeve was removed it was noted to be partially open toward the proximal end.Additionally, it was noted that there was a slit in the outer sleeve in the area in which the ifu is stored.The two inner packaging sleeves were removed from the outer sleeve.It was noted that a small tear was on the label portion of the inner packaging for the dilator/sheath.It was noted that the sheath is partially flattened at distal portion.The delivery system inner packaging was inspected, a large tear in the label portion of the packaging.The pusher catheter was noted to be bent.It is unknown when or how these tears occurred.The manner in which the delivery system was received by the facility and the manner in which the device was shipped to bpv for evaluation could have contributed to the noted tears, flattening, and bends.Shipping damage evaluation: a review of all shipping damage for this device was conducted.In 2016, only two complaints were reported for shipping damage.Therefore, this event will be considered an isolated event.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the device was returned.Based on the returned sample and condition of the sample, the investigation can be confirmed for a packaging issue related to the open outer packaging.Based on the available information, the definitive root cause was unknown.It was if unknown shipping factors contributed to the event.Labeling review: the current ifu (instructions for use) states: warnings: contents are supplied sterile.Do not use if the product sterilization barrier or its packaging is compromised.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 the inner packaging pouch was allegedly open as it was removed from the box.There was no reported patient involvement.

• Brand Name: DENALI FEMORAL SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6019284
• MDR Text Key: 57057125
• Report Number: 2020394-2016-00947
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801(17)181231(10)GFZK3530B
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: DL900F
• Device Lot Number: GFZK3530B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• 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