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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. SYRINGE 10ML SALINE XS
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BECTON, DICKINSON AND CO. SYRINGE 10ML SALINE XS Back to Search Results
Catalog Number 306572
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that syringe 10ml saline xs had a poor seal on the packaging.This occurred on 2 occasions.The following information was provided by the initial reporter: nurses have found posiflush where the packaging is not sealed, making the product not sterile.
 
Manufacturer Narrative
H6: investigation summary a device history record review was completed for provided lot number 0335954.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.As neither picture nor physical samples were available for return, a thorough sample analysis could not be completed.Based on the limited investigation results regarding the production of the affected lot, an exact cause related to the manufacturing process could not be determined for this incident.Further action has not been determined necessary at this time.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.H3 other text : see h10.
 
Event Description
It was reported that syringe 10ml saline xs had a poor seal on the packaging.This occurred on 2 occasions.The following information was provided by the initial reporter: nurses have found posiflush where the packaging is not sealed, making the product not sterile.
 
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Brand Name
SYRINGE 10ML SALINE XS
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
MDR Report Key12286159
MDR Text Key265355139
Report Number9616657-2021-00072
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 08/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2023
Device Catalogue Number306572
Device Lot Number0335954
Was Device Available for Evaluation? No
Date Manufacturer Received08/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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