MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ CAP TIP SYR LL/LS STER LF PP NAT 50/TRAY

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 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8149998.Medical device expiration date: 2023-05-31.Device manufacture date: 2018-05-29.Medical device lot #: 8087811.Medical device expiration date: 2023-03-31.Device manufacture date: 2018-03-28.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 tips of bd¿ cap tip syr ll/ls ster lf pp nat 50/tray had foreign matter inside before use.

Event Description

It was reported that tips of bd¿ cap tip syr ll/ls ster lf pp nat 50/tray had foreign matter inside before use.

Manufacturer Narrative

Investigation summary: two photos and six 50-count tip cap trays were received in original packaging with seals intact.A visual examination confirms three were from batch #8087811 (p/n 305822) cavityies 00 and 01, and three were from batch #8149998 (p/n 305822) cavity 01.One tip cap, from batch #8149998 of cavity #a59, in the given samples was observed to have an embedded foreign matter defect with a particle smaller than level 3 in size, which is acceptable per product specification.However, when viewing the photos one tip can be seen with embedded foreign matter defect present covering approximately 1/3 of the tip cap¿s visible material.The defect observed in the photo is rejectable per product specification.The tray in the photo is opened and batch # is unknown.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the reported defect.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.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.

• Brand Name: BD¿ CAP TIP SYR LL/LS STER LF PP NAT 50/TRAY
• Type of Device: CAP
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8216467
• MDR Text Key: 132078162
• Report Number: 1213809-2018-00977
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

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: Health Professional
• Device Catalogue Number: 305822
• Device Lot Number: SEE H.10.
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 12/18/2018
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other