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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 50ML LL CLEAR 14GA 1-1/4IN
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BECTON DICKINSON, S.A. SYRINGE 50ML LL CLEAR 14GA 1-1/4IN Back to Search Results
Catalog Number 309742
Device Problem Inappropriate Audible Prompt/Feedback (2280)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/17/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 syringe 50ml ll clear 14ga 1-1/4in pump alarms.The following information was provided by the initial reporter: the mistake does not happen when using b.Braun syringes.The customer wants to receive new syringes.The pump shows locking alarm after 80%.Background: the syringes are filled in the pharmacy with opiates and used in the labor room.
 
Event Description
It was reported that syringe 50ml ll clear 14ga 1-1/4in pump alarms.The following information was provided by the initial reporter: the mistake does not happen when using b.Braun syringes.The customer wants to receive new syringes.The pump shows locking alarm after 80%.Background: the syringes are filled in the pharmacy with opiates and used in the labor room.
 
Manufacturer Narrative
H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lot 1911207, no deviations or non-conformances related to this issue were identified during the manufacturing process.Throughout the manufacturing process, force testing and silicone content tests are conducted for each lot.Testing results were reviewed for lot 1911207 and all results were found to be within required limits.Ten retained samples of lot 1911207 were used for additional evaluation.The product was visually inspected, no damaged or molding defects were observed and silicone content and breakout force testing verified product met required specifications.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the available information we are not able to determine a root cause at this time.
 
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Brand Name
SYRINGE 50ML LL CLEAR 14GA 1-1/4IN
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key11170428
MDR Text Key226846473
Report Number3003152976-2021-00030
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 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309742
Device Lot Number1911207
Was Device Available for Evaluation? No
Date Manufacturer Received01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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