MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP

Catalog Number 301029

Device Problems Moisture Damage (1405); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (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 before use of the bd 10ml syringe luer-lok¿ tip the syringes were found with water/humidity on the inside.There was no report of injury or medical intervention.

Manufacturer Narrative

Dhr review for batch 7150685 (p/n 301029).Manufacturing dates: 06/14/2017 ¿ 6/17/2017.Batch quantity was 428,400.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Silicone weight testing was performed as per requirement with all test results within acceptable range per product specification.Batch 7150685 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Sample evaluation: no physical samples were returned for evaluation.Two photos were received by bd canaan.Barrel roofs of four 10ml assembled syringes could be seen in the photos with the stoppers in the breakout position.Small droplets were visible on the roofs of the barrels.The droplets are most likely silicone that is used in the syringe assembly process.No stringing and no pooling of silicone was observed.The amount present did not appear excessive based on the two photos provided.Our product specification for silicone content is 2.0 to 7.0 mg.Furthermore, the bd product spec is tied to the latest update of iso 7886 for syringes which specifies that silicone appearance shall be minimized.Silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel.Silicone has been in use in this application for over 20 years.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.Conclusion: the investigation could not confirm the reported defect.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 SYRINGE LUER-LOK¿ TIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7024940
• MDR Text Key: 92904751
• Report Number: 1213809-2017-00310
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 301029
• Device Lot Number: 7150685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2017
• 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