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: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD LUER-LOK¿ 5 ML CONVENIENCE TRAY; 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
 

BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD LUER-LOK¿ 5 ML CONVENIENCE TRAY; PISTON SYRINGE Back to Search Results
Model Number 309703
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2021
Event Type  malfunction  
Event Description
It was reported that 2627 bd luer-lok¿ 5 ml convenience trays had issues with scale marking permanency.The following information was provided by the initial reporter: "there have been multiple instances of excessive rejected syringes that have had unclear and missing graduation marks.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the 4 photos submitted for evaluation.The reported issue was confirmed upon inspection of the photos.A device history record review showed there was an error during the production of this batch.During the portion of manufacturing associated with the printing process it was noted that several products had the markings scraped off during manufacturing.An automated quality alert was generated at the time of production and steps were made to correct the manufacturing error and defective products were removed from the line.There is a possibility some defective products made it through inspection, resulting in this failure.
 
Event Description
It was reported that 2627 bd luer-lok¿ 5 ml convenience trays had issues with scale marking permanency.The following information was provided by the initial reporter: "there have been multiple instances of excessive rejected syringes that have had unclear and missing graduation marks.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD LUER-LOK¿ 5 ML CONVENIENCE TRAY
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX  
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13169459
MDR Text Key285766357
Report Number9610847-2021-00636
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903097037
UDI-Public30382903097037
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number309703
Device Catalogue Number309703
Device Lot Number1179674
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-