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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE FLUSH
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BECTON DICKINSON, S.A. 10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE FLUSH Back to Search Results
Catalog Number 306575
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Erythema (1840)
Event Date 11/26/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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 after the customer used a 10 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9%, the patient developed red spots in the face, on the thorax, and lower extremities.The patient was admitted with a referral from a general practitioner.No other medical intervention information was reported.
 
Manufacturer Narrative
Investigation summary: no photos or samples were returned for evaluation.A bhr for the reported batch was conducted confirming this was released according to defined specifications and requirements including sterilization and final lab testing.There were no qn's or issues associated with batch #7124237.There is no documentation for any issue affecting the saline solution, which could be related to the reported issue.All inspections performed from filling to case pack were acceptable.Controls in place at manufacturing site have been reviewed and found acceptable including: bioburden tested during week days (monday to friday).Overkill sterilization process.The sterilization process is challenged and re-qualified annually.Environmental testing within the filling area on a weekly basis.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 daily.Bioburden testing on the components used to assemble the syringes, performed during week days.Continuous online monitoring of the wfi water quality (note: this is for toc and conductivity, not microbial requirements).Bioburden and endotoxin testing of the usp purified water and wfi systems, performed during week days.Weekly endotoxin testing of the pure steam system.The saline solution lots #7117195 and #7117198 have also been reviewed: no problems, defects or qn related to the reported issue were found.The evaluation did not reveal any specific circumstances, from manufacturing process, that could explain the described complaint.Not possible to determine a root cause.Since the defect is not confirmed and this is the first complaint received for this defect, no actions are required.This log number and incident will be monitored for identification of emerging trends and for future occurrence in order to driving appropriate corrective and preventive actions.
 
Event Description
It was reported that after the customer used a 10 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9%, the patient developed red spots in the face, on the thorax, and lower extremities.The patient was admitted with a referral from a general practitioner.No other medical intervention information was reported.
 
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Brand Name
10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
Type of Device
SALINE FLUSH
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
MDR Report Key8166591
MDR Text Key130466022
Report Number3002682307-2018-00305
Device Sequence Number1
Product Code NGT
UDI-Device Identifier00382903065752
UDI-Public382903065752
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 12/26/2018
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 Health Professional
Device Expiration Date04/30/2020
Device Catalogue Number306575
Device Lot Number7124237
Initial Date Manufacturer Received 11/26/2018
Initial Date FDA Received12/14/2018
Supplement Dates Manufacturer Received11/26/2018
Supplement Dates FDA Received12/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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