MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ SYRINGE WITH BD LUER-LOK¿ TIP

Catalog Number 309653

Device Problems Device Contamination with Chemical or Other Material (2944); Moisture or Humidity Problem (2986)

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

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.No lot # provided.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that before use, a bd¿ syringe with bd luer-lok¿ tip was found with foreign matter as¿ there was moisture inside of the syringe, two white spots appeared to be some sort of growth.¿ there was no report of injury or medical intervention reported.

Manufacturer Narrative

Investigation summary: photo/ sample revealed 2 white dots on face of syringe no sign of moisture just a slight ring.Product within specification? yes.No.2 white dots are bubbles.Moisture is silicone.Investigation conclusion: root cause for 2 white dots- these white dots are bubbles that come from molding vents on mold partially plugged with plastic gas discharge preventing/obstructing primary vent discharge or mold melt disk probes partially obstructed which creates a jetting effect in the plastic flow.In turn, this creates head and uneven flow through the gates and causes bubbles.Moisture in syringe: 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, however, some silicone may not be perfectly distributed.Silicone has been in use in this application for over 20 years, with estimated distribution well in excess of 25 billion units.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.

• Brand Name: BD¿ SYRINGE WITH BD LUER-LOK¿ TIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7290475
• MDR Text Key: 101003755
• Report Number: 1911916-2018-00028
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096535
• UDI-Public: 30382903096535
• 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: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309653
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Date Manufacturer Received: 01/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other