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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE Back to Search Results
Catalog Number 306595
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Edema (1820); Rash (2033); Dizziness (2194); Discomfort (2330)
Event Date 11/22/2018
Event Type  Injury  
Manufacturer Narrative
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 when the "filled solution of flush was pushed to 2 - 3ml marking" on the bd posiflush¿ normal saline syringe, the patient "felt dizzy and uncomfortable", and "developed throat edema and rash" after injecting.It was also reported that the patient "felt normal after being injected with 10mg of dexamethasone for 1 hour".
 
Event Description
It was reported that when the "filled solution of flush was pushed to 2 - 3ml marking" on the bd posiflush¿ normal saline syringe, the patient "felt dizzy and uncomfortable", and "developed throat edema and rash" after injecting.It was also reported that the patient "felt normal after being injected with 10mg of dexamethasone for 1 hour".
 
Manufacturer Narrative
Investigation summary: two (2) samples were received for evaluation.They are in the sealed flow wrap, they have the plunger rod-rubber stopper, the tip cap and saline solution.The barrel labels confirm the lot# 8019839.Controls in place, at the manufacturing site: bioburden tested on a weekly basis.An overkill sterilization process is used.Environmental testing within the filling area is done on a biweekly basis.The sterilization process is challenged and re-qualified annually.The solution is filtered twice before it is filled in syringes (note: once when transferring to the hold tank and again at the fill machine).Endotoxin testing is performed on each batch.Fill room operators are trained and qualified on gowning for the fill room environment on an annual basis.Weekly bioburden testing on the components used to assemble the syringes.Continuous online monitoring of the wfi water quality (note: this is for toc and conductivity, not microbial - weekly bioburden and endotoxin testing of the usp purified water and wfi systems.Weekly endotoxin testing of the pure steam system.Each sterilizer is thoroughly validated before used for posiflush sterilization.Additional lab analysis was completed on the returned samples and both sample passed with no issues found.Root cause for the reported issue is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.
 
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Brand Name
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
MDR Report Key8161655
MDR Text Key130263860
Report Number1911916-2018-00731
Device Sequence Number1
Product Code NGT
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,health professional,o
Type of Report Initial,Followup
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2021
Device Catalogue Number306595
Device Lot Number8019839
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2018
Date Manufacturer Received11/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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