MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿

Catalog Number 305959

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 bd plastipak¿ hypodermic syringe luer lok¿ had plunger sliding difficulty during use.No reports serious injury or medical intervention noted.

Manufacturer Narrative

Investigation results: no samples or pictures were received by our quality team for investigation to verify the plunger was difficult to move.Ten retained 10ll lot 1704025p samples were evaluated.On visual inspection of these ten retained samples, no damage or molding defect can be observed in any of them.A device history record review found no non-conformances associated with this issue during production of this batch.A review of the results of silicone weight, break out and sustaining force tests performed during the manufacturing process of lot 1704025p was performed and they were all within specification limits.Silicone weight, break out and sustaining force tests were also performed with the ten retained samples with the results meeting specification limits.According to results obtained during manufacturing process and results obtained with retained samples, no manufacturing defect has been found in the syringes that could have caused the alleged defect.Based on the investigation, the root cause of this incident could not be determined.Based on an evaluation of severity and frequency it was determined that no capa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿
• Type of Device: HYPODERMIC SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7228919
• MDR Text Key: 98982292
• Report Number: 3003152976-2018-00007
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 305959
• Device Lot Number: 1704025P
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other