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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. SAFEDAY IV ADMINISTRATION SET

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B. BRAUN DOMINICAN REPUBLIC INC. SAFEDAY IV ADMINISTRATION SET Back to Search Results
Catalog Number 352899
Device Problems Leak/Splash (1354); Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). One used iv tubing set, without packaging, was received for evaluation. The set was subjected to an air pressure (leakage) test according to specification with acceptable results. During the clamp performance test, the roller clamp was engaged along three different sections of the tubing to test for leakage. During each test period, there was no air flow through the set when the roller clamp was closed. In an attempt to replicate the reported incident, the set was spiked to a bag of normal saline and primed. There were no leakages at the end of the set when the roller clamp was closed; the roller clamp functioned properly. Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number. Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event. The returned sample met requirements according to specification, and the reported failure could not be reproduced. 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 on the set is not holding. The clamp is closed, but by the time the clinician gets the iv started, the clamp has opened and has soaked the floor and patient bed.
 
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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 Key5947330
MDR Text Key55005563
Report Number9614279-2016-00062
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 08/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/16/2019
Device Catalogue Number352899
Device Lot Number0061508434
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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