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

Catalog Number 309604

Device Problems Structural Problem (2506); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

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 there are connectivity issues when attaching the needle to a 10 ml bd luer-lok¿ tip syringe "causing air to get into the syringe" risking injury and potential leaking.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: the lot was manufactured on line 6 in 2 days with 4 shifts with a total of 25 hours during which the production is monitored through the frequency rit0225ctis01-08 rev.01, where they evaluated product characteristics in the assembly stage such as : syringe assembled correctly (visual method), syringe without damage (visual method), syringe without contamination in liquid passage or external (visual method vs drawing), during this stage no problem or defective piece is reported attributable to the defect that the client reports.The lot was inspected according to the current work instruction with satisfactory results for the characteristics required for its approval including functional tests.It should be mentioned that the product not compliant with folio pnc-18-140 is not attributable to the defect that the client reports, the product was selected and inspected for quality having conforming results.It is important to mention that the batch mentioned by the customer that they were working with (7272826) was manufactured in the bd plant in cannan and the batch 7292704 was manufactured in the bd cuautitlan plant, so the client's perception of having different products could be causing conflict.The luer-lok design has a rope around the pivot that allows you to screw and secure the needle perfectly, it is compatible with all bd hypodermic needles, it is suggested to use bd wrinkles and for the appropriate medication as indicated in the image.For such the claim is ruled as unconfirmed.Investigation conclusion: the device was not assembled with the needle correctly.

• 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: 7508679
• MDR Text Key: 108239861
• Report Number: 9614033-2018-00024
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 309604
• Device Lot Number: 7292704
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other