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 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: 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 has been reported that two cap tip syr ll/ls ster lf pp nat 50/tray have been found containing foreign matter before use.The following has been provided by the initial reporter: the user complained that foreign matter was found on the surface on a tip cap.

Manufacturer Narrative

H.6.Investigation summary: three photos, one loose tip cap and one unopened 50-count tip cap tray from confirmed to be from batch 8149998 (p/n 305822) were received and evaluated.The tray was opened and all the tip caps inside were visually inspected with one of the tip caps was observed to contain a brown embedded foreign matter.The loose tip cap was also observed to contain a brown embedded foreign matter.In both cases the fm was present on the inner and outer cylinders.It appeared to be burnt plastic and was larger than level 3 in size, which was rejectable per product specification.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 8149998 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.

Event Description

It has been reported that two cap tip syr ll/ls ster lf pp nat 50/tray have been found containing foreign matter before use.The following has been provided by the initial reporter: the user complained that foreign matter was found on the surface on a 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: 8834053
• MDR Text Key: 153846107
• Report Number: 1213809-2019-00773
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

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 Expiration Date: 05/31/2023
• Device Catalogue Number: 305822
• Device Lot Number: 8149998
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other