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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH
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BECTON DICKINSON, S.A. BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306585
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Date 08/08/2022
Event Type  malfunction  
Event Description
It was reported that the culture sample taken from the bd posiflush¿ normal saline syringe produced microbial growth.The following information was provided by the initial reporter: "some patients (around a total of 6 patients) started having infections at the hospital and the staff decided to take culture samples from all of the solutions that are used at the hospital.They also took 1culture sample from our prefilled saline syringes (posiflush sp 10 ml) and proliferation (growth) was observed at the culture sample that was taken.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this.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 the culture sample taken from the bd posiflush¿ normal saline syringe produced microbial growth.The following information was provided by the initial reporter: "some patients (around a total of 6 patients) started having infections at the hospital and the staff decided to take culture samples from all of the solutions that are used at the hospital.They also took 1culture sample from our prefilled saline syringes (posiflush sp 10 ml) and proliferation (growth) was observed at the culture sample that was taken.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 15-aug-2022.H6: investigation summary a device history record review was completed for provided material number 306585 lot number 2019361.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, three syringes from lot number 2019361 were returned for evaluation by our quality engineer team.The samples arrived well packaged to avoid any damage and none of the samples were used.Unfortunately, as the sterility test requires 40 syringes, we were unable to perform the sterility testing on the samples provided by the customer.Forty (40) retained samples from the reported lot number were obtained and have been tested for sterility.The test results showed no microbial growth after 14 days.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for this incident.
 
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Brand Name
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
Type of Device
SALINE VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP  22520
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP   22520
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15353172
MDR Text Key301996676
Report Number3002682307-2022-00230
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306585
Device Lot Number2019361
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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