MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ ORAL DISPENSING SYRINGE 10 ML; LIQUID MEDICATION DISPENSER

Catalog Number 305219

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: n/a.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

Material no.305219 batch no.9206533.It was reported that before use of the bd¿ oral dispensing syringe 10 ml the facility is finding some kind of lubricant in their 10 ml syringes.The following information was provided by the initial reporter: they are finding some kind of lubricant in their 10 ml syringes¿lot # 9206533.

Manufacturer Narrative

H.6.Investigation summary: two boxes with samples were received, all confirmed to be from batch #9206533 (p/n 305219).One box contained three sealed and one opened bag of 10ml oral syringes.They were visually evaluated.All syringes were observed to have a small amount of silicone present on the stopper surface and the barrel wall in the fluid path.One smaller box was submitted for ftir ( fourier transform infrared spectroscopy) testing of the samples.The spectral analysis shows that this material is most likely silicone.The amount of silicone observed was normal and expected amount for this product per product specification.No defects were observed in the samples received.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.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.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.H3 other text : see section h.10.

Event Description

Material no.305219; batch no.9206533.It was reported that before use of the bd¿ oral dispensing syringe 10 ml the facility is finding some kind of lubricant in their 10 ml syringes.The following information was provided by the initial reporter: they are finding some kind of lubricant in their 10 ml syringes¿lot # 9206533.

• Brand Name: BD¿ ORAL DISPENSING SYRINGE 10 ML
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9511529
• MDR Text Key: 194150788
• Report Number: 1213809-2019-01298
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305219
• Device Lot Number: 9206533
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other