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

Catalog Number MN1820

Device Problem Insufficient Information (3190)

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

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned and no photos were provided for review.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any deficiency with the needle in respect to the alleged bleeding.Limited information was provided surrounding the event; therefore, a definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural factors contributed to the reported event.It should be noted that the instructions for use (ifu) provides information to mitigate the risk of product use as well as possible complications.The ifu states: "this product should be used by a physician who is completely familiar with the indications, contraindications, limitations, typical findings and possible side effects of core needle biopsy, in particular, those relating to the specific organ being biopsied." additionally, ¿warnings: good medical judgment should be exercised in considering biopsy on patients who are receiving anticoagulant therapy or who have a bleeding disorder.¿ the ifu further states: "potential complications associated with core biopsy procedures are site specific and include, but are not limited to: hematoma; hemorrhage; infection; adjacent tissue injury; pain; bleeding; hemoptysis; hemothorax; non-target tissue, organ or vessel perforation; pneumothorax; and air embolism.Air embolism is a rare but serious potential complication of lung biopsy procedures.Rapid deterioration of neurological status and/or cardiac arrhythmia may be indicative of air embolism.Prompt diagnosis and treatment must be considered if the patient exhibits signs or symptoms of air embolism." it is unknown if other factors continued to the reported event.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate.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 a prostate biopsy, the patient allegedly presented bleeding.The patient was reported as in serious condition.

• Brand Name: BARD MAGNUM CORE BIOPSY NEEDLE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7603932
• MDR Text Key: 111142693
• Report Number: 2020394-2018-00878
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00801741084355
• UDI-Public: (01)00801741084355
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K934370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: MN1820
• Device Lot Number: REBQ2556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR