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 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that cap tip syr ll/ls ster lf pp nat 50/tray contained foreign matter.The following information was provided by the initial reporter: "complaint from kwong wah hospital.The user complained that black dirt were found inside the tip cap.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 2020-05-21.H.6.Investigation summary two photos and one opened 50-count tray of tip caps was received and evaluated.It was observed one of the tip caps contained small black and brown embedded foreign matter particles.The particles appeared to be burnt plastic with at least one particle larger than level 3 in size which was rejectable per product specification.The tip cap was from cavity a58.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.Potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded foreign matter 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.No corrective actions are necessary based on the defective rate identified.Batch 9078939 is considered in compliance with our product specification requirements.Furthermore, 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.

Event Description

It was reported that cap tip syr ll/ls ster lf pp nat 50/tray contained foreign matter.The following information was provided by the initial reporter: "complaint from (b)(6) hospital.The user complained that black dirt were found inside 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: 10072271
• MDR Text Key: 199125455
• Report Number: 1213809-2020-00318
• 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: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 305822
• Device Lot Number: 9078939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other