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

Catalog Number 309657

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the plunger ¿did not glide easily¿ on a bd luer-lok¿ disposable syringe with bd luer-lok¿ tip.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: samples were received for evaluation.The samples were sent to the quality control laboratory to perform a silicone content test and displacement test (breakout and sustaining force).Results were obtained and passed with acceptable quality limits therefore, the complaint is unconfirmed.Furthermore, 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 manufactured in line 2 in 3 days with 7 shifts with a total of 56 hours during which the production is monitored through the frequency rit0225ctis01-04 rev.17, during the manufactured, no event or report is mentioned of non-conformity that could be attributable to the defect that the client reports.The lot was inspected by quality control by taking a sample of 6 pieces with an acceptance criterion with 1 rejection and with 0 being approved, the results was conformed.The lot was inspected according to the current work instruction with satisfactory results for the characteristics required for its approval including functional tests a revision was made to the stopper washing and lubrication record, which shows that the stopper was washed and lubricated prior to its use, no event was presented attributable to the defect that the client communicates.Investigation conclusion: in conclusion and with the results from customer samples in the quality control laboratory, results were obtained according to silicon content (presence of lubricant) with an aql = 1.0% and with displacement test (breaking and holding force) with an aql = 0.40% so the complaint is unconfirmed.

• Brand Name: BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
• 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: 7293126
• MDR Text Key: 101016200
• Report Number: 9614033-2018-00001
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• PMA/PMN Number: K110771
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 309657
• Device Lot Number: 7230907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Date Manufacturer Received: 01/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other