• 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 DE MEXICO BD LUER-LOK¿ TIP 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 DE MEXICO BD LUER-LOK¿ TIP SYRINGE Back to Search Results
Catalog Number 309604
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/21/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that a bd luer-lok¿ tip syringe separated during use causing no suction therefore, it would not draw. There was no report of injury or medical interventions.
 
Manufacturer Narrative
400 samples were received, and a sample evaluation was performed. When carrying out the packing integrity test on the sample of the pieces received from the customer, it is shown that if the defect is presented. It is attributable to the handling of the samples since they arrived in a box hit, the pieces scattered around the box. Regarding plunger displacement it should be mentioned that the silicone content is within specification. The defect is not generated during manufacturing, but can be generated during the shipping process. A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect. The lot was inspected according to the current work instruction with satisfactory results for the characteristics required for its approval including functional tests. The lot was manufactured in line 4 in 2 days with 3 shifts with a total of 24 hours during which the production is monitored through the frequency rit0225ctis01-04 rev. 11, in the assembly stage attributes such as: syringe assembled correctly by means of visual method vs drawing, syringe without damage visual method, among others, the sampling is 40 pieces per hour, completing a total sample size of 960 pieces with a limit of acceptance of 0 and rejection of 1. No non-conforming parts were registered. The lot was inspected according to the current work instruction with satisfactory results for the characteristics required for its approval including functional tests. The defect is not generated during manufacturing, but can be generated during the shipping process and based on the engineering study this defect has an aql
=
0. 25%. 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 business team regularly reviews the collected data for identification of emerging trends.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD LUER-LOK¿ TIP SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
MDR Report Key7342163
MDR Text Key102629717
Report Number9614033-2018-00006
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096047
UDI-Public30382903096047
Combination Product (y/n)N
PMA/PMN Number
K151766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 04/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2022
Device Catalogue Number309604
Device Lot Number7171627
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/15/2018 Patient Sequence Number: 1
-
-