MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD LUER-LOK¿ TIP SYRINGE

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.

• Brand Name: BD LUER-LOK¿ TIP SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 7342163
• MDR Text Key: 102629717
• Report Number: 9614033-2018-00006
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096047
• UDI-Public: 30382903096047
• Combination Product (y/n): N
• PMA/PMN Number: K151766
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 309604
• Device Lot Number: 7171627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 02/21/2018
• Supplement Dates FDA Received: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other