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 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 before use of the cap tip syr ll/ls ster lf pp nat 50/tray there was an issue with foreign matter on the tip of the cap.Tow caps had this issue.The following information was provided by the initial reporter: there is foreign material on the tip cap.

Manufacturer Narrative

H.6.Investigation summary: two photos, one opened tip cap tray and seven fully sealed tip cap trays with a total of 395 tip caps from batch 9078938 (p/n 305822) were received and evaluated.It was observed seven of the 395 tip caps contained black embedded foreign matter particles that appeared to be burnt plastic.Three of the seven tip caps had particles larger that level 1 in size and were acceptable per product specification.Four of the seven tip caps had particles larger than level 3 in size and were rejectable per product specification.The tip caps were from the following cavities: a53, a38, a57, a2, a11, a34 and a55.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.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 9078938 is considered in compliance with our product specification requirements.

Event Description

It was reported that before use of the cap tip syr ll/ls ster lf pp nat 50/tray there was an issue with foreign matter on the tip of the cap.Tow caps had this issue.The following information was provided by the initial reporter: there is foreign material 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: 9070306
• MDR Text Key: 194025186
• Report Number: 1213809-2019-00932
• 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: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 305822
• Device Lot Number: 9078938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other