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: BECTON DICKINSON HUNGARY KFT (BD) ULTRASAFE PLUS X100L PNG CLEAR; INTRAVASCULAR ADMINISTRATION SET
  • 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
 

BECTON DICKINSON HUNGARY KFT (BD) ULTRASAFE PLUS X100L PNG CLEAR; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 47451130
Device Problems Break (1069); Difficult or Delayed Activation (2577)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: the customer issued a complaint for a detached syringe detected by end user.Photos were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.Based on investigation conclusion a syringe can only become detached if syringe capture features or the flange of the syringe get damaged/broken or if the syringe receives an impact after syringe insertion which causes it to unclip from the device.Therefore, the syringe most likely became detached as it was not clipped into the device properly or it received an external impact after syringe insertion which caused it to unclip from the device.None of these causes are related to bd process.
 
Event Description
It was reported that a ultrasafe plus x100l png clear had a broken safety device before use.The following was reported by the initial reporter: "after opening the package it was discovered that the syringe is defective.The needle shield cap is partially inside the spring.The glass medicine vial can move in and out of the safety device.The syringe was not used.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/16/2021.H.6.Investigation: the customer issued a complaint for a detached syringe detected by end user.Photos and 1 sample were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.Based on investigation conclusion a syringe can only become detached if syringe capture features or the flange of the syringe get damaged/broken or if the syringe receives an impact after syringe insertion which causes it to unclip from the device.Therefore, the syringe most likely became detached as it was not clipped into the device properly or it received an external impact after syringe insertion which caused it to unclip from the device.None of these causes are related to bd process.
 
Event Description
It was reported that a ultrasafe plus x100l png clear had a broken safety device before use.The following was reported by the initial reporter: "after opening the package it was discovered that the syringe is defective.The needle shield cap is partially inside the spring.The glass medicine vial can move in and out of the safety device.The syringe was not used.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ULTRASAFE PLUS X100L PNG CLEAR
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON HUNGARY KFT (BD)
uveggyar utca 3
kornye tatabanya 2851
HU  2851
MDR Report Key11738357
MDR Text Key268514833
Report Number3009081593-2021-00025
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2022
Device Catalogue Number47451130
Device Lot Number7061120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2021
Date Manufacturer Received07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-