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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

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BECTON DICKINSON, S.A. BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE Back to Search Results
Catalog Number 300865
Device Problems Leak/Splash (1354); Failure to Deliver (2338)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 12/15/2020
Event Type  Injury  
Manufacturer Narrative
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 the bd plastipak¿ 50ml concentric luer lock syringe experienced difficult plunger movement and was involved with a serious injury -hypotension. The following information was provided by the initial reporter: sku 187508 syringe 50ml luer lock bd n300865 1 x 60. Syringe infusion pumps ¿ drug delivery failure. It became most notable during phase 1 of the pandemic. We had changed over from old pumps to new pumps, and we initially thought it was a programming issue. To alleviate it we increased the pump occlusion pressure but this did not help. We took syringe samples to our physics lab which showed a high pressure across the system. It convincingly became a syringe issue when we started to get the same issue in theatre using the old pumps. Any harm on a patient? -thankfully no long-term harm but several patients had significant hypotensive episodes when noradrenaline failed.
 
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Brand NameBD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11405532
MDR Text Key244760103
Report Number3003152976-2021-00117
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/03/2021 Patient Sequence Number: 1
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