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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ POSIFLUSH HEPARIN SYRINGE; UNKNOWN

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BECTON DICKINSON UNSPECIFIED BD¿ POSIFLUSH HEPARIN SYRINGE; UNKNOWN Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problems Syncope (1610); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Reaction (2414)
Event Date 05/23/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.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.The customer's address is unknown.(b)(6) has been used as a default.  a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the unspecified bd¿ posiflush heparin syringe product caused a reaction in the patient.The nurse was present during the time of event.The patient experienced heart complications, fainting, extreme blood pressure 64/40, low heart rate and excessive vomiting.Leakage occured at the pic-line site however, no reports of blood exposure occurred.No further information given at this time.
 
Manufacturer Narrative
Investigation summary: prior to the report of infection evaluated in (b)(4), there was no trend for infection or reaction cases reported for franklin product.This complaint is part of a new trend which began in april 2018, capa (b)(4) was initiated to address this issue.As no lot number was provided, a dhr review could not be completed.Samples and/or pictures were not provided for evaluation.Investigation conclusion: a review of all lot sterility testing performed for product released between april 2018 & may 2018 confirmed that no organism growth was identified for any lots released during the shelf life of this product.The root cause analysis of the reported infection/reaction cases under capa (b)(4) as not identified a direct causation between the infections and the bd franklin product.
 
Event Description
It was reported that the unspecified bd¿ posiflush heparin syringe product caused a reaction in the patient.The nurse was present during the time of event.The patient experienced heart complications, fainting, extreme blood pressure 64/40, low heart rate and excessive vomiting.Leakage occured at the pic-line site however, no reports of blood exposure occurred.No further information given at this time.
 
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Brand Name
UNSPECIFIED BD¿ POSIFLUSH HEPARIN SYRINGE
Type of Device
UNKNOWN
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key7592161
MDR Text Key110784553
Report Number2243072-2018-00360
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 07/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Nurse
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 05/23/2018
Initial Date FDA Received06/12/2018
Supplement Dates Manufacturer Received05/23/2018
Supplement Dates FDA Received07/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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