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: B. BRAUN B. BRAUN MINISPIKE DISPENSING PIN
  • 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
 

B. BRAUN B. BRAUN MINISPIKE DISPENSING PIN Back to Search Results
Model Number 412012
Device Problems Material Discolored (1170); Device Damaged Prior to Use (2284); Contamination of Device Ingredient or Reagent (2901); Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Date 09/14/2016
Event Type  malfunction  
Event Description
An opened b braun minispike dispensing pin ref #412012 was found to have visible contamination within the package.Several black specs of material were observed and what appeared to be a small area of discoloration on the paper backing of the package.Incident was reported to b braun and the sample has been returned to them for investigation.All material from that lot has been removed from use until an investigation can occur.Only one unit was found to have a visible issue and that unit appeared to still have wrapper integrity.No other problems noted on remaining product that lot and other lots available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
B. BRAUN MINISPIKE DISPENSING PIN
Type of Device
B. BRAUN MINISPIKE DISPENSING PIN
Manufacturer (Section D)
B. BRAUN
bethlehem PA 18018
MDR Report Key5962772
MDR Text Key55267586
Report NumberMW5064837
Device Sequence Number1
Product Code LHI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2021
Device Model Number412012
Device Lot Number0061498040
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2016
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-