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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. STANDARD EXTENSION SET WITH CARESITE® STANDARD EXTENSION SET WITH CARESITE VALVE

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B. BRAUN DOMINICAN REPUBLIC INC. STANDARD EXTENSION SET WITH CARESITE® STANDARD EXTENSION SET WITH CARESITE VALVE Back to Search Results
Catalog Number 354220
Device Problem Air Leak (1008)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b. Braun medical inc. Internal report # (b)(4). The actual device involved in the reported incident was not returned for evaluation. 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
Reports air bubbles in the tubing. Follow-up correspondence with the reporter indicated that the air bubbles seen in the tubing ranged in size (both large and small bubbles were seen). Normal saline solution was in the line at the time. The set was connected to a hospira primary plumset (item # (b)(4); however, the air bubbles were only seen in the b. Braun extension set. The rn's tried flicking and not flicking the luer access devices during priming with the same results. The rn's indicated that they wasted about 50ml of saline just trying to get most of the bubbles out.
 
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Brand NameSTANDARD EXTENSION SET WITH CARESITE®
Type of DeviceSTANDARD EXTENSION SET WITH CARESITE VALVE
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 Key6046882
MDR Text Key58600305
Report Number9614279-2016-00072
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153293
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 09/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number354220
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 Received09/26/2016
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

Patient Treatment Data
Date Received: 10/21/2016 Patient Sequence Number: 1
Treatment
HOSPIRA PRIMARY PLUMSET (ITEM # (B)(4)
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