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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD POSIFLUSH SYRINGE
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BECTON DICKINSON UNSPECIFIED BD POSIFLUSH SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Shock (2072); Reaction (2414)
Event Date 08/06/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: 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.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that the patient had a reaction to unspecified bd¿ posiflush syringe.This was discovered after use.The following information was provided by the initial reporter: information requested on posiflush and the excipients of the sodium chloride 0.9% solution contained in the syringe.I have requested this information from bd product manager, who has escalated this request internally.During our conversation she had mentioned that the reason she requested this info is that a patient had apparently had an adverse reaction to posiflush.She was given this information by a nurse who had seen the patient recently.The patient had said they were previously being treated in hospital, posiflush was used and that the crash team were subsequently called to attend.(possible cardiac arrest).It is now supposedly noted on the patients notes that the patient has a reaction to posiflush, however, that a saline vial can be used.
 
Event Description
It was reported that the patient had a reaction to unspecified bd¿ posiflush syringe.This was discovered after use.The following information was provided by the initial reporter: information requested on posiflush and the excipients of the sodium chloride 0.9% solution contained in the syringe.I have requested this information from bd product manager, who has escalated this request internally.During our conversation she had mentioned that the reason she requested this info is that a patient had apparently had an adverse reaction to posiflush.She was given this information by a nurse who had seen the patient recently.The patient had said they were previously being treated in hospital, posiflush was used and that the crash team were subsequently called to attend.(possible cardiac arrest).It is now supposedly noted on the patients notes that the patient has a reaction to posiflush, however, that a saline vial can be used.
 
Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.H3 other text : see h.10.
 
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Brand Name
UNSPECIFIED BD POSIFLUSH SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key10457831
MDR Text Key204530921
Report Number2243072-2020-01314
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 foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received08/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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