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 50ML CONCENTRIC LUER LOCK 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 50ML CONCENTRIC LUER LOCK SYRINGE Back to Search Results
Catalog Number 300865
Device Problem Leak/Splash (1354)
Patient Problem Chemical Exposure (2570)
Event Date 03/05/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd plastipak¿ 50ml concentric luer lock syringe experienced leakage and led to chemotherapy drug exposure.It has not been specified whether medical intervention was administered as a result.The following information was provided by the initial reporter: as mentioned by telephone, we have again noticed a leak in the plunger of a 50ml syringe ref 300865 (batch 2010099).This time the syringe has been kept and can be sent to you for expertise.However, the incident occurred during the preparation of an expensive cytotoxic product.Due to the defect in the syringe, the chemotherapy had to be re-prepared.The incident resulted in leakage of cytotoxic product and thus exposure of the personnel in the chemotherapy preparation unit.In one of these cases.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10/d11: concomitant medical products: device available for eval?: yes.D10/d11: concomitant medical products: returned to manufacturer on: 3/29/2021.H.6.Investigation: one used sample was returned to our quality team for investigation.Through visual inspection, no leakage past the stopper ribs was observed.The product was disassembled for further inspection, there was no damage or molding defects noted in the plunger rod or other components that could have caused a leak and the stopper was verified to be properly assembled onto the plunger rod.A device history review was performed for the lot 2010099, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.H3 other text : see h.10.
 
Event Description
It was reported that the bd plastipak¿ 50ml concentric luer lock syringe experienced leakage and led to chemotherapy drug exposure.It has not been specified whether medical intervention was administered as a result.The following information was provided by the initial reporter: as mentioned by telephone, we have again noticed a leak in the plunger of a 50ml syringe ref 300865 (batch 2010099).This time the syringe has been kept and can be sent to you for expertise.However, the incident occurred during the preparation of an expensive cytotoxic product.Due to the defect in the syringe, the chemotherapy had to be re-prepared.The incident resulted in leakage of cytotoxic product and thus exposure of the personnel in the chemotherapy preparation unit.In one of these cases.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key11593710
MDR Text Key243701720
Report Number3003152976-2021-00178
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 05/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number2010099
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2021
Initial Date Manufacturer Received 03/05/2021
Initial Date FDA Received03/30/2021
Supplement Dates Manufacturer Received05/05/2021
Supplement Dates FDA Received05/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-