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: BD¿ PRN ADAPTER; INTRAVASCULAR CATHETER
  • 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
 

BD¿ PRN ADAPTER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 388638
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/16/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported when using the bd¿ prn adapter there was foreign matter in fluid pathway.The following information was provided by the initial reporter.The customer stated: "black foreign bodies were found in the new prn.The package was not opened, and a new prn was taken, which had no impact on the patient.".
 
Manufacturer Narrative
Investigation summary: a device history review was conducted for lot number 1070561.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
 
Event Description
It was reported when using the bd¿ prn adapter there was foreign matter in fluid pathway.The following information was provided by the initial reporter.The customer stated: "black foreign bodies were found in the new prn.The package was not opened, and a new prn was taken, which had no impact on the patient.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD¿ PRN ADAPTER
Type of Device
INTRAVASCULAR CATHETER
MDR Report Key12563074
MDR Text Key283618190
Report Number3014704491-2021-00176
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,other,user facility
Type of Report Initial,Followup
Report Date 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number388638
Device Lot Number1070561
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/03/2021
Initial Date FDA Received10/01/2021
Supplement Dates Manufacturer Received10/08/2021
Supplement Dates FDA Received11/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-