MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER TIP CAP, STERILE TRAY; LIQUID MEDICATION DISPENSER

Catalog Number 305822

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/02/2018

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 with the use of the bd luer tip cap, sterile tray there was an issue with foreign matter.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: one tray of 50 cap tips was received, confirmed to be from batch #5201798 (p/n 305822).The sample was visually evaluated.One of the cap tips was found to have a small black piece of embedded foreign matter larger than level 3 in size.The foreign matter the size observed is rejectable per product specification.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.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.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 potential root cause for the embedded foreign matter defect is associated with the molding process.No corrective actions are necessary based on the defective rate identified.

Event Description

It was reported with the use of the bd luer tip cap, sterile tray there was an issue with foreign matter.There was no report of injury or medical intervention.

• Brand Name: BD LUER TIP CAP, STERILE 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: 8085923
• MDR Text Key: 127866549
• Report Number: 1213809-2018-00800
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305822
• Device Lot Number: 5201798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Date Manufacturer Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other