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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. 10 ML BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE, IN 10 ML SYRINGE; PREFILLED SALINE FLUSH SYRINGE
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BECTON, DICKINSON AND CO. 10 ML BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE, IN 10 ML SYRINGE; PREFILLED SALINE FLUSH SYRINGE Back to Search Results
Catalog Number 306553
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Date 03/10/2018
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that a (b)(6), male patient with a diagnosis of medulloblastoma and a port had a positive blood culture for serratia marcescens on (b)(6) 2018.The patient was treated and discharged.The pfge patterns for this incident are indistinguishable from the original co outbreak pattern.The device implicated with this incident is a 10 ml bd posiflush¿ sterile field (sf) saline syringe, in 10 ml syringe.
 
Event Description
It was reported that a 10 year old, male patient with a diagnosis of medulloblastoma and a port had a positive blood culture for serratia marcescens on (b)(6) 2018.The patient was treated and discharged.The pfge patterns for this incident are indistinguishable from the original co outbreak pattern.The device implicated with this incident is a 10 ml bd posiflush¿ sterile field (sf) saline syringe, in 10 ml syringe.
 
Manufacturer Narrative
Samples unavailable, complaint was not raised on a specific lot number of posiflush sf or sp.Complaint raised in association with an fda investigation of infections in patients with central lines whose treatment involved the use of posiflush sp, sf, and heparin lock syringes.Lot number unknown.Dhr - n/a - lot number unknown.- the provided lot numbers for this complaint were reviewed and concluded not to be manufactured in drogheda.Manufacturing review: the organism associated with the complaint was identified as serratia marcescens.A review of environmental monitoring data from 2015-2018 and bioburden ids confirmed that the organism has never been recorded at the drogheda site.Unconfirmed.Investigation comments- n/a (no sample or lot).Other action taken: there is no morphological evidence of serratia marcescens ability to survive the moist heat sterilization process.During the validation and annual re-validation of the drogheda steam sterilizers, the plant uses spore forming thermophilic gram positive rod shaped geobacillus stearmothermophillus s a biological indicator.The formation of endospores has not been reported in any species of serratia, thus its resistance to steam sterilization is scientifically remote.In addition, it is a mobile organism with growing conditions of 5-40 degrees celsius, well below the moist heat sterilization temperature of 121 degrees celsius.Investigation conclusion: root cause: a batch number was not supplied in this instance.However, in accordance with cpr-033, situational analysis, a three year review of complaints, environmental monitoring results, water test results and quality notifications was performed.Records indicate that there were no recorded occurrences of s.Marcescens organism in the drogheda plant.In addition, drogheda posiflush product is terminally sterilized with moist heat sterilization.The sterilization process is requalified annually to demonstrate sterility assurance level of >10.
 
Manufacturer Narrative
Correction: due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device evaluated by mfr: device returned to manufacture: no.
 
Event Description
It was reported that a 10 year old, male patient with a diagnosis of medulloblastoma and a port had a positive blood culture for serratia marcescens on (b)(6) 2018.The patient was treated and discharged.The pfge patterns for this incident are indistinguishable from the original co outbreak pattern.The device implicated with this incident is a 10 ml bd posiflush¿ sterile field (sf) saline syringe, in 10 ml syringe.
 
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Brand Name
10 ML BD POSIFLUSH¿ STERILE FIELD (SF) SALINE SYRINGE, IN 10 ML SYRINGE
Type of Device
PREFILLED SALINE FLUSH SYRINGE
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
MDR Report Key7576090
MDR Text Key110333360
Report Number9616657-2018-00028
Device Sequence Number1
Product Code NGT
UDI-Device Identifier30382903065531
UDI-Public30382903065531
Combination Product (y/n)N
PMA/PMN Number
K153481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 08/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number306553
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age10 YR
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