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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
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BECTON, DICKINSON AND CO. BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9% Back to Search Results
Catalog Number 306572
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Date 04/24/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was use and then the next morning the patient developed a fever and was admitted to the clinic.The following information was provided by the initial reporter: a customer we informed about safety information - mds-20-1971 reported the following complaint to us today.¿because of the safety information, the packaging was checked for damage, no perforation was visible, then used for catheter irrigation.The next morning, patient developed a fever and was admitted to the clinic.¿.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval uation? yes? d.10 returned to manufacturer on: (b)(6) 2020.H.6.Investigation summary a device history record review was performed for provided lot number 9248167 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, seven physical samples were returned for evaluation by our quality engineer team.During the production process, twenty units per hour are inspected to confirm blister package and sterile barrier integrity, eight units per shift are subjected to burst testing to further ensure the sterile barrier, endotoxin bioburden, assay, and ph testing of saline is performed prior to release and during the syringe filling process, bioburden samples are taken daily prior to sterilization for testing, and environmental monitoring of the fill room is performed bi-weekly.All finished product is also tested for signs of any potential contaminants or abnormalities.This testing is in place to ensure that the product is fit for its intended use and meets all standard requirements.Based on the investigation results, it is unlikely that the posiflush syringe contributed to this reported incident.Our quality team will continue to monitor the production process for any potential defects or emerging trends.
 
Event Description
It was reported that bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was use and then the next morning the patient developed a fever and was admitted to the clinic.The following information was provided by the initial reporter: a customer we informed about safety information - mds-20-1971 reported the following complaint to us today.¿because of the safety information, the packaging was checked for damage, no perforation was visible, then used for catheter irrigation.The next morning, patient developed a fever and was admitted to the clinic.¿.
 
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Brand Name
BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
MDR Report Key10182417
MDR Text Key196068107
Report Number9616657-2020-00096
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
NA
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 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2022
Device Catalogue Number306572
Device Lot Number9248167
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2020
Date Manufacturer Received06/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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