MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS CAP TIP SYR LL/LS STER LF PP NAT 50/TRAY; LIQUID MEDICATION DISPENSER

Catalog Number 305822

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

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

Event Date 12/23/2019

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, a supplemental report will be filed.

Event Description

It was reported that the cap tip syr ll/ls ster lf pp nat 50/tray experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: foreign material on the tip cap.There are black particles on the tip cap.

Manufacturer Narrative

H.6.Investigation summary: forty-six tip caps in an opened tray from batch 9078941 (p/n 305822) were received and evaluated.It was observed one of the tip caps contained multiple black embedded foreign matter particles.The particles appeared to be burnt plastic with several larger than level 3 in size, which were rejectable per product specification.The tip cap was from a-45.Potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded fm is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.Per procedure, after start up, all molded parts are scrapped until no degraded plastic is observed.If this is not performed thoroughly a piece with this condition can get through.This type of defect is cosmetic and does not pose risk to the customer.No corrective actions are necessary based on the defective rate identified.Batch 9078941 is considered in compliance with our product specification requirements.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

It was reported that the cap tip syr ll/ls ster lf pp nat 50/tray experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: foreign material on the tip cap.There are black particles on the tip cap.

• Brand Name: CAP TIP SYR LL/LS STER LF PP NAT 50/TRAY
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9558436
• MDR Text Key: 194527368
• Report Number: 1213809-2019-01337
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 305822
• Device Lot Number: 9078941
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other