Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE; PISTON SYRINGE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON, S.A. BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 300865
Device Problems Leak/Splash (1354); Failure to Deliver (2338)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Event Date 11/05/2020
Event Type  malfunction  
Manufacturer Narrative
Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.(b)(4).Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lot 2007034, no deviations or non-conformances related to this issue were identified during the manufacturing process.Ten retained samples of the same lot were used for evaluation, no damage or molding defect observed.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned, and all retained samples were within specifications.Root cause description: lubricant is employed during syringe assembly process to lubricate the cylinders in the silicone station.Silicone employed in this product is a medical grade silicone authorized to this kind of products according to iso-7886-1 (max.Value 0.25mg/cm2).During manufacturing process break out force, sustaining force and silicone content tests are done per lot according to procedures pc-030 and pc-017.On checking the results for lot 2007034, they are within specification limits according to procedure jg-500 (for 50ml syringes: break out force max.9 lbs, sustaining force max.5 lbs; silicone weight ref: 6mg, max: 25mg).Break out force, sustaining force and silicone content tests are done with the 10 retained samples of lot 2007034 finding the results for the three tests between specifications limits previously mentioned.According to inspection plan procedure jg-500, 200 units are inspected every 2 pallets by quality control team.In addition, final products in this manufacturing line, for this reference and lot size are sampled by operator and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures (jg-301, jg-302, jg-303 and jg-304) since manufacturing record stablished that all production and quality processes were carried out normally, and tests performed with retained samples are within specification limits, the root cause of the alleged defect cannot be determined.Rationale: based on qda limits for this product and defect no corrective action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our quality team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the bd plastipak¿ concentric luer lock syringe had difficult plunger movement, causing the pressure increase alarm on the electric syringe pump to trigger.The following information was provided by the initial reporter, translated from french to english: "patient on noradrenaline in electric syringe pump (pse).During syringe relays on the pump, the pressure increase alarm was triggered, without reaching the maximum pressure of 100 mmhg the noradrenaline syringe had been prepared in advance, less than 4 hours before the relay according to the service procedure.Due to this increase in pressure, the pump was switched back to the first syringe (which was not yet completely empty) the time it took to prepare another syringe.Observed clinical consequences : the patient was in prone position.He had a hypotension + an important bradycardia which motivated a passage in dorsal decubitus (to be able to carry out a cardiac massage if a cardiac arrest occurred).Precautionary measures and actions taken : patient returned to supine position, change of syringes.The pump seen by biomedical failure not related to the pump itself, the pump has fulfilled its mission alarmed under pressure manipulation of the syringe not connected to the patient, after event, the doctor finds a blockage of the plunger when he pushes manually.".
 
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 2007034, no deviations or non-conformances related to this issue were identified during the manufacturing process.Ten retained samples of the same lot were used for evaluation, no damage or molding defect observed.Lubricant is employed during the syringe assembly process to lubricate the cylinders in the silicone station.The silicone employed in this product is a medical grade silicone authorized for product use.Throughout the manufacturing process, force testing and silicone content tests are conducted for each lot.All retained samples were evaluated and found to be within required specifications.Based on the available information we are not able to determine a root cause at this time.
 
Event Description
It was reported that the bd plastipak¿ concentric luer lock syringe had difficult plunger movement, causing the pressure increase alarm on the electric syringe pump to trigger.The following information was provided by the initial reporter, translated from french to english: "patient on noradrenaline in electric syringe pump (pse).During syringe relays on the pump, the pressure increase alarm was triggered, without reaching the maximum pressure of 100 mmhg the noradrenaline syringe had been prepared in advance, less than 4 hours before the relay according to the service procedure.Due to this increase in pressure, the pump was switched back to the first syringe (which was not yet completely empty) the time it took to prepare another syringe.Observed clinical consequences : the patient was in prone position.He had a hypotension + an important bradycardia which motivated a passage in dorsal decubitus (to be able to carry out a cardiac massage if a cardiac arrest occurred).Precautionary measures and actions taken : patient returned to supine position, change of syringes.The pump seen by biomedical failure not related to the pump itself, the pump has fulfilled its mission alarmed under pressure manipulation of the syringe not connected to the patient, after event, the doctor finds a blockage of the plunger when he pushes manually.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key11089575
MDR Text Key227975652
Report Number3003152976-2020-00589
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 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number2007034
Was Device Available for Evaluation? No
Date Manufacturer Received03/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age82 YR
Patient Weight78
-
-