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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%; PREFILLED SALINE SYRINGE
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BECTON, DICKINSON AND CO. BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; PREFILLED SALINE SYRINGE Back to Search Results
Catalog Number 306572
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 05/26/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).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 an unspecified number of bd posiflush¿ xs pre-filled flush syringes nacl 0.9% experienced damaged or open unit package(s)/seal(s) where sterility was compromised.Product defect was noted prior to use.The following information was provided by the initial reporter: the presence of two syringes with packaging with a hole on lot 0044501.
 
Manufacturer Narrative
H.6.Investigation summary a device history record review was performed for provided lot number 0044501 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, two picture samples were returned for evaluation by our quality engineer team.Through examination of the pictures, the product packages were observed damaged.The appearance of this defect is identical to an issue recently communicated through a field safety notice; however, the batch referenced in this incident was produced on a different production line than the defective product captured within the field safety notice.At this time an exact cause for this incident cannot be determined.Our quality team will continue to monitor the production process for signs of this potential defect and any signs of emerging trends.H3 other text : see h.10.
 
Event Description
It was reported that an unspecified number of bd posiflush¿ xs pre-filled flush syringes nacl 0.9% experienced damaged or open unit package(s)/seal(s) where sterility was compromised.Product defect was noted prior to use.The following information was provided by the initial reporter: the presence of two syringes with packaging with a hole on lot 0044501.
 
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Brand Name
BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
Type of Device
PREFILLED SALINE SYRINGE
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
MDR Report Key10162966
MDR Text Key199893979
Report Number9616657-2020-00091
Device Sequence Number1
Product Code NGT
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 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2023
Device Catalogue Number306572
Device Lot Number0044501
Was Device Available for Evaluation? No
Date Manufacturer Received05/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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