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

Catalog Number 309657

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2018

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 that the customer had 7 instances where the plunger will not go down when pushed on the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip.There was no report of exposure, serious injury or medical intervention.

Event Description

It was reported that the customer had 7 instances where the plunger will not go down when pushed on the bd luer-lok disposable syringe with bd luer-lok tip.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Correction: awareness date changed from: (b)(6) 2018 and corrected to (b)(6) 2018.Date received by manufacturer: 7/7/2018.

Event Description

It was reported that the customer had 7 instances where the plunger will not go down when pushed on the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: no samples or photos displaying the condition reported were received for examination.Ten retention samples were sent for evaluation on plunger rod pull put force, breakout and sustaining force for the plunger rod-stopper inside the barrel, and lubricant presence.When performing the functional tests to the retention samples to ensure the conformity of the product and be able to evaluate the defect that the client reported, the results were satisfactory and did not present any problem, so the defect that the client reports was not reproducible.The lot was approved and inspected according to the current work instruction with satisfactory results for the characteristics required for its approval including functional tests.As part of the functional tests performed during the final inspection of the product is the silicone content test, for such the batch.It was approved and inspected according to the current work instruction with satisfactory results for the characteristics required for its approval including functional tests.The complaint is not confirmed since in the documentary review of the manufacturing of the lot no problem was identified attributable to the defect that the client reports, in addition the retention samples presented satisfactory results.Investigation conclusion: the problem of non-siliconized cork is ruled out, this is because the siliconized cork stopper records were checked, which were complied with, likewise during the manufacturing process there are no reported failures in the displacement of the cork (jam) on the transportation rails, which is why also meets.Giving out this possible cause.The failure mode relating to faults in silicon spray is also ruled out there are no records of equipment stoppages due to this failure or any intervention to it by this event.Giving out this possible cause correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture.

• Brand Name: BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 7690399
• MDR Text Key: 114432137
• Report Number: 9614033-2018-00046
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• PMA/PMN Number: K151766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 309657
• Device Lot Number: 7319963
• Date Manufacturer Received: 07/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other