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 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 12 cap tip syr ll/ls ster lf pp nat 50/trays experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: complaint from usr facility.The user complained that black foreign particles were found inside the packing and the syringe cap.

Event Description

It was reported that 12 cap tip syr ll/ls ster lf pp nat 50/trays experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: complaint from user facility.The user complained that black foreign particles were found inside the packing and the syringe cap.

Manufacturer Narrative

H.6.Investigation: two photos and twelve fully sealed 50-count tip cap trays from batch 8212539 (p/n 305822) were received and evaluated.It was observed six tip caps contained black and/or foreign matter particles.Two tip caps appeared to contain an ink particle attached to the bottom equal to level 2 in size and were acceptable per product specification.Four tip caps appeared to contain burnt plastic particles.Two contained particles equal to or larger than level 2 in size and were acceptable per product specification.Two contained particles larger than level 3 in size and were rejectable per product specification.Six of the trays were observed to contain black and brown particles attached to the underside of the top web.The particles appeared to be contamination with two of the trays containing particles larger than level 2 in size and were 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.The potential root cause for the top web contamination is associated with the top web supplier 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.H3 other text : see h.10.

• 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: 8976079
• MDR Text Key: 157403141
• Report Number: 1213809-2019-00908
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 305822
• Device Lot Number: 8212539
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other