MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MAGNUM CORE BIOPSY NEEDLES; BIOPSY INSTRUMENT

Catalog Number MN1620

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 08/12/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 kidney biopsy through normal density tissue, the patient developed a renal hematoma one day after the procedure.No coaxial was used and the device was not dry fired outside of the patient.The procedure was completed using another device.Additional medical treatment was required post procedure.

Event Description

It was reported that during an ultrasound guided kidney biopsy through normal density tissue, the patient developed a renal hematoma one day after the procedure.No coaxial was used and the device was not dry fired outside of the patient.The procedure was completed using another device.Additional medical treatment was required post procedure.

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

• Brand Name: MAGNUM CORE BIOPSY NEEDLES
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7936706
• MDR Text Key: 122796630
• Report Number: 2020394-2018-01856
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00801741084317
• UDI-Public: (01)00801741084317
• Combination Product (y/n): N
• PMA/PMN Number: K934370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MN1620
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 52