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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD PRM/N35/STD/50CM; INFUSION SET CONNECTOR
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BECTON DICKINSON BD PRM/N35/STD/50CM; INFUSION SET CONNECTOR Back to Search Results
Catalog Number 515573-ZAT
Device Problem Complete Blockage (1094)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2019
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.Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
 
Event Description
It was reported that ten bd prm/n35/std/50cm experienced air in the syringe/tube.The customer reported, "when connecting with terumo chemo safe infusion set, air got mixed and occlusion occurred frequently.".
 
Manufacturer Narrative
Per additional information, this incident is no longer considered reportable.Air bubbles within the device are not considered likely to affect the operation of the device or cause serious injury to the user.
 
Event Description
It was reported that ten bd prm/n35/std/50cm experienced air in the syringe/tube.The customer reported, "when connecting with terumo chemo safe infusion set, air got mixed and occlusion occurred frequently.".
 
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Brand Name
BD PRM/N35/STD/50CM
Type of Device
INFUSION SET CONNECTOR
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key8461814
MDR Text Key141082769
Report Number2243072-2019-00596
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
PMA/PMN Number
N/A
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 04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2020
Device Catalogue Number515573-ZAT
Device Lot Number1811212C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2019
Date Manufacturer Received03/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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