MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. PARSONNET VASCULAR PROBE

Catalog Number 007603

Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

No device, no medical records or no medical images have been made available to the manufacturer.The lot number for the device has been provided.A review of the device history records is currently being performed.The investigation of the reported event is currently underway.

Event Description

It was reported that the packaging seal of the vascular probe was open when 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 & functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed.Medical records: no medical records were provided for review.Image/photo review: reviewing with the packagers, team leader and section manager it appears that we are seeing the chevron end of the pouch that is open, and given the slightly ragged appearance of the tyvek edge, the appearance is that the tyvek itself has been cut or torn.This is not something that could happen in packaging.In addition, we have two units in this complaint (complaints (b)(4)) that are each from a different lot, processed two months apart.The odds are very slim that we could have one parsonnet that shipped in february, and one that shipped in april, through medtronic and to the same end user that both exhibit the same open pouch characteristic.Conclusion: two photos were provided for review.Based upon the photos provided, the investigation is inconclusive for the alleged packaging issues, as it can not be determined when the breach of sterile barrier occurred with the product.While the photo shows open packaging, it is unknown if handling and procedural events outside of bard's control contributed to the alleged issue.Per the photos received, additional packaging can be seen on the device that is not part of the bard approved packaging.(b)(4) places the additional packaging on the device and seals the packaging.Additionally, they place hospital specific stickers on the packaging of the devices.Once the additional packaging has been added, the devices are than packed in a box which is delivered to the hospital by the hospital's specific courier service.It is unknown the impact that the additional packaging has on the original packaging.However, the root cause is most likely related to the additional packaging and handling that is not in bard's control.Labeling review: the current ifu (instructions for use) states: precautions: 1.This device should be used only by physicians qualified in cardiovascular and peripheral vascular surgery techniques.2.Sterile, unless the package is opened or damaged.Single use only.3.These products are sterilized by ethylene oxide.Do not resterilize.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.

• Brand Name: PARSONNET VASCULAR PROBE
• Type of Device: VASCULAR PROBE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5212781
• MDR Text Key: 31060756
• Report Number: 2020394-2015-01821
• Device Sequence Number: 1
• Product Code: DWP
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 007603
• Device Lot Number: GFZA1230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2015
• 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