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. 50 ML BD PLASTIPAK LUER-LOK 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. 50 ML BD PLASTIPAK LUER-LOK SYRINGE Back to Search Results
Catalog Number 300223
Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field."multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1808352, medical device expiration date: 2023-10-31, device manufacture date: 2018-08-14; medical device lot #: 1805360, medical device expiration date: 2023-04-30, device manufacture date: 2018-05-21; medical device lot #: 1811351, medical device expiration date: 2023-10-31, device manufacture date: 2018-11-05." initial reporter phone #: unknown.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 the coating of the syringe is very smooth so that the syringe cannot be handled properly in combination with sterile gloves with the 50 ml bd plastipak¿ luer-lok¿ syringe.The following information was provided by the initial reporter: the coating of the syringe is very smooth so that the syringe cannot be handled properly in combination with sterile gloves.This causes a disruption to the preparation process in the pharmaceutical preparation department.The print (graduation scale) is also considerably lighter in color than other previously used syringes.This concerns article v62.300223.Batch numbers: 1805360/1811351/1808352.
 
Event Description
It was reported the coating of the syringe is very smooth so that the syringe cannot be handled properly in combination with sterile gloves with the 50 ml bd plastipak¿ luer-lok¿ syringe.The following information was provided by the initial reporter: the coating of the syringe is very smooth so that the syringe cannot be handled properly in combination with sterile gloves.This causes a disruption to the preparation process in the pharmaceutical preparation department.The print (graduation scale) is also considerably lighter in color than other previously used syringes.This concerns article v62.300223 batch numbers 1805360/1811351/1808352.
 
Manufacturer Narrative
H.6.Investigation: two samples were returned to our quality engineer for investigation.Upon inspecting the samples, the scale on one product was noted to be slightly lighter than the other.The entire logo and scale were printed and legible, no defect was observed.We did not identify any foreign matter or coating on the product when evaluated.Syringes were filled with water using gloves, there was no difficultly in handling the product.A device history review was performed for reported lots 1805360, 1811351 and 1808352, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issues.Based on the available information, we are not able to determine a root cause at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
50 ML BD PLASTIPAK LUER-LOK SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key8470412
MDR Text Key147095936
Report Number3003152976-2019-00230
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 04/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300223
Device Lot NumberSEE H.10
Date Manufacturer Received03/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-