MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIOPSY PROBE; BIOPSY INSTRUMENT

Catalog Number ECP0110GV

Device Problems Disconnection (1171); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2015

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation 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 opening the device packaging, the tube that connects to the sample tray was allegedly disconnected.Another probe was able to perform the procedure.There was no patient involvement.

Manufacturer Narrative

After further clinical review, this event was reassessed and determined to be not mdr reportable.Although, this event is not mdr reportable, an initial mdr has already been submitted; therefore, this supplemental report is being submitted to document the change in reportability and additional details.Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Visual/microscopic inspection: the probe was clean and the aperture was (b)(4) closed.The saline cap was not returned.No other anomalies were noted.The probe was examined via x-ray imaging prior to functional testing.The examination showed both of the front stops to be intact on the front housing.Functional/performance evaluation: the vacuum tubing was returned detached from the rear seal cap on the sample chamber.The vacuum tubing was reconnected to the rear seal cap, however, the tube did not make a tight connection.The inside of the tubing was swabbed and the residue was analyzed.The results indicate that the residue swabbed from the interior of the tubing is an (b)(4) percent match to a known silicone compound.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: one electronic photo was returned and reviewed.The photo shows a probe sample trap chamber and tubing set.The sample tray/basket is present in the chamber.The vacuum tubing is seen to be detached from the rear seal cap on the sample chamber.Based on the photo review, the reported detachment can be confirmed.Conclusion: one probe was returned for evaluation.Based on the returned device and photo review, the investigation is confirmed for the reported detachment, as the tubing was returned detached from the rear of the sample chamber.The investigation is confirmed a product quality issue, as a minimal amount of silicone was present on the vacuum tubing.The scan of the returned samples indicated that there was silicone present on the probe tubing.Silicone on the tubing most likely contributed to the tubing detaching from the sample chamber.Labeling review: the current instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.(b)(4).

• Brand Name: ENCOR BIOPSY PROBE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5352579
• MDR Text Key: 35669667
• Report Number: 2020394-2015-02097
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K040842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: ECP0110GV
• Device Lot Number: VT15D0180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2015
• 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