• 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 DOMINICAN REPUBLIC INC. SAFEDAY IV 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
 

B. BRAUN DOMINICAN REPUBLIC INC. SAFEDAY IV ADMINISTRATION SET Back to Search Results
Catalog Number 352899
Device Problem Device Slipped (1584)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). There were no samples received for evaluation in connection with the reported incident. Multiple attempts made to contact the facility to obtain additional information regarding this event were unsuccessful. Without the actual sample or lot number, a thorough sample analysis or batch record review could not be performed and no specific conclusions can be drawn. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number. If additional pertinent information becomes available a follow-up report will be filed.
 
Event Description
As reported by the user facility: reports the roller clamp is not clamping.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSAFEDAY IV ADMINISTRATION SET
Type of DeviceSAFEDAY IV ADMINISTRATION SET
Manufacturer (Section D)
B. BRAUN DOMINICAN REPUBLIC INC.
las americas industrial park
km22 autopista las americas
santo domingo, dominican republic
DR
Manufacturer Contact
eric roden
las americas industrial park
km22 autopista las americas
santo domingo, dominican republic 
DR  
5491000
MDR Report Key6067348
MDR Text Key59220103
Report Number9614279-2016-00073
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K955585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number352899
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2016
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

-
-