MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 10ML HYPODERMIC SYRINGE LUER LOK¿

Catalog Number 305959

Device Problems Particulates (1451); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.(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 there was foreign matter ¿particulate¿ found in bd plastipak¿ 10ml hypodermic syringe luer lok¿ before use.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: no samples or pictures have been received for investigation.Dhr of lot 1709010 has been reviewed finding an annotation regarding the alleged defect.During assembly process, polypropylene particles were detected inside the syringes.Once detected, defective product detected was rejected to scrap and barrel hoppers in molding area were empty.Manufacturing line was stopped and cleaned to eliminate particles.Polypropylene particles can come from molding and transport processes.The areas where pieces are transported are protected to avoid damage on product.Ten retained samples of lot 1709010 are evaluated.Upon visual inspection of these ten samples, no particle or foreign matter can be observed inside the syringes.Based on this retained samples evaluation, on all the preventive measures and our stringent in ¿process inspection plan, we are certain that this should be an isolated issue.Final products in this manufacturing line, for this reference and lot size are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Visual inspection: molding: 2 injections per shift.Printing: 24 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Assembly: 24 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Primary packaging: 1 advance-step (without product) per hour, after any intervention in the equipment, and once at the beginning of the shift.Secondary packaging: 1 shelf-package per pallet.Functional inspection: printing: once in the first pallet and once in last pallet of the lot.Assembly: once in the first pallet and once in last pallet of the lot.Primary packaging: once in the first pallet and once in last pallet of the lot.Investigation conclusion: polypropylene particles can come from molding and transport processes.Based on this retained samples evaluation, on all the preventive measures and our stringent in ¿process inspection plan, we are certain that this should be an isolated issue.

• Brand Name: BD PLASTIPAK¿ 10ML HYPODERMIC SYRINGE LUER LOK¿
• Type of Device: HYPODERMIC SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7331663
• MDR Text Key: 102324913
• Report Number: 3003152976-2018-00071
• Device Sequence Number: 1
• Product Code: FMF
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 305959
• Device Lot Number: 1709010
• Date Manufacturer Received: 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other