Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MAGNUM DISPOSABLE NEEDLE; BIOPSY INSTRUMENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. MAGNUM DISPOSABLE NEEDLE; BIOPSY INSTRUMENT Back to Search Results
Catalog Number MN1825
Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/15/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation of the reported event 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 prostate biopsy in normal density tissue, after delivering anesthesia through the cannula of the needle, the operator allegedly found the cannula difficult to remove from the patient.Reportedly, upon removal from the patient, the cannula was bent a few centimeters from the tip.It was further reported that the procedure was completed with another device and a coaxial was not used.There was no reported patient injury.
 
Event Description
It was reported that during an ultrasound-guided prostate biopsy in normal density tissue, after delivering anesthesia through the cannula of the needle, the operator allegedly found the cannula difficult to remove from the patient.Reportedly, upon removal from the patient, the cannula was bent a few centimeters from the tip.It was further reported that the procedure was completed with another device and a coaxial was not used.There was no reported patient injury.
 
Manufacturer Narrative
A lot history review was conducted and it was determined that a device history record (dhr) review was not required, however requested.The device history records have been reviewed and this 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 to date for this lot number and failure mode.One magnum biopsy needle and four electronic photos were provided for review.Based on the sample evaluation and photo review, the investigation is confirmed for a bent cannula needle.The return sample and photos note slight cannula shaft damage and a bend point at approximately 25.8mm from the cannula tip.However, no other anomalies were noted.The investigation is inconclusive for difficult to remove due the return sample condition and as specific event conditions, (i.E.Patient tissue), could not be replicated.Per the reported event details, the physician "proceeded to infiltrate the anesthesia through the cannula of the magnum needle".The instructions for use (ifu) states: "the biopsy procedure must be performed using appropriate aseptic technique.Prepare the site as required.Adequate anesthesia should be administered prior to incision of the skin." therefore, as the magnum needle is not labeled for use in the administration of anesthetic, it is likely that procedural factors contributed to the reported event.A user related letter will be sent to the facility regarding the investigation and device instructions for use.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.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MAGNUM DISPOSABLE NEEDLE
Type of Device
BIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7820787
MDR Text Key118395483
Report Number2020394-2018-01574
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00801741084362
UDI-Public(01)00801741084362
Combination Product (y/n)N
PMA/PMN Number
K934370
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2020
Device Catalogue NumberMN1825
Device Lot NumberRECN2871
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2018
Date Manufacturer Received11/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age70 YR
-
-