MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GEL MARK ULTRA MARKER

Catalog Number GMUEC10GSS

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that two weeks after the breast tissue marker was placed, one of the gel pellets came out of the access site.No additional treatment was provided.No patient injury was reported.

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 malfunction pursuant to 21 cfr part 803.A manufacturing review could not be performed, as the lot number was not provided.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 patient and/or procedural issues contributed to the event.The current gel mark ultra breast biopsy marker instructions for use (ifus) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.Despite good faith efforts to obtain additional information, the complainant/report was unable or unwilling to provide any further patient, product, or procedural details to bard.

• Brand Name: GEL MARK ULTRA MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4, bangpoo industrial estate; samutprakarn province 1028 0; TH 10280
• Manufacturer Contact: linda morocho ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4909731
• MDR Text Key: 6833985
• Report Number: 2020394-2015-00948
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GMUEC10GSS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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