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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON PRM/N35/STD/50CM PRIMING SET

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BECTON DICKINSON PRM/N35/STD/50CM PRIMING SET Back to Search Results
Catalog Number 515573-ZAT
Device Problem No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2019
Event Type  Malfunction  
Manufacturer Narrative

Oem manufacturer: 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. Date of event: unknown. Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.

 
Event Description

It was reported that the prm/n35/std/50cm was connected to the terumo infusion set as a side tube to flow saline through, but when attempting to run chemo through the spike set, it wouldn't flow through, resulting in the replacement of the prm/n35/std/50cm. The following information was provided by the initial reporter: "used terumo infusion set as a main route. Connected 515573-zat as a side tube and flowed saline. Connected with the spike set and hcp tried to flow chemo, however it didn't flow even pressed the bag of chemo. Replaced by new 515573-zat and the drug started to flow. ".

 
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Brand NamePRM/N35/STD/50CM
Type of DevicePRIMING SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8441031
MDR Text Key139542883
Report Number2243072-2019-00541
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER,USER FACILITY
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/21/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number515573-ZAT
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/18/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2019
Was Device Evaluated By Manufacturer? Yes
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: 03/21/2019 Patient Sequence Number: 1
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