MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONTROL MODULE

Catalog Number CM3000230

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2014

Event Type  Injury  

Manufacturer Narrative

After further clinical review of this event with bard's medical department, this event was reassessed and determined to be mdr reportable as a serious injury pursuant to 21 cfr part 803.The serial number was provided and the device history records are being reviewed.The device has not been returned for evaluation to date.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 during an ultrasound-guided breast biopsy, after the first lesion was completed the monitor screen went blank.Another probe was placed and there was no change with the monitor status.The system was sent in for maintenance and the biopsy procedure was rescheduled.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records were reviewed.The 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 reported for this lot number and issue to date.Visual inspection: the sample was not returned.Functional/performance evaluation: the sample was not returned.Medical records review: medical records were not provided.Image/photo review: images were not provided.Conclusion: the investigation is inconclusive, as the sample was not returned for evaluation.The definitive root cause could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.Labeling review: the current instructions for use (ifu) states: precautions: - this equipment is intended for use by qualified personnel only - locate the senorx encor system as far as possible from other electronic equipment to minimize interference - inspect accessories and cords for breaks, cracks, nicks, or other damage before every use.If damaged, do not use.Failure to observe this precaution may result in injury or electrical shock to the patient or to the operator.- connect the power cord to a hospital grade wall outlet having the correct voltage or product damage may result.Operation: - for handheld accessory devices follow the specific instructions for use included with each accessory.- note: if the system fails during use, check rear panel for blown fuse.Replace as needed.

• Brand Name: CONTROL MODULE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): DYMAX CORP.; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5006882
• MDR Text Key: 23226999
• Report Number: 2020394-2015-01226
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• PMA/PMN Number: K040842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CM3000230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other