MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE WITH NEEDLE; PISTON SYRINGE

Catalog Number 301940

Device Problem Fungus in Device Environment (2316)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 3600 bd syringes with needle were found with "suspected mildew" on them before use, and black spots were seen on the outside of the packaging.The following information was provided by the initial reporter, translated from (b)(6) to english: "the equipment department found that when the large package was opened, suspected mildew was found on the appearance of part of the package.A total of 2 goods were admitted to hospital this time.Among them, most of the packages were glued to each other, and there were many black spots on the outside.".

Manufacturer Narrative

H.6.Investigation summary a device history record review was performed for provided lot number 1906102 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, seven picture samples were returned for evaluation by our quality engineer team.Through examination of the picture samples, black particles were observed on the shelf carton surface.It has been determined that this incident resulted from some sort of water damage during the storage or transportation process post production.A manufacturing related cause could not be identified for this type of defect.Our quality engineer team will continue to monitor the production process for signs of this potential defect and any emerging trends.

Event Description

It was reported that 3600 bd syringes¿ with needle were found with "suspected mildew" on them before use, and black spots were seen on the outside of the packaging.The following information was provided by the initial reporter, translated from chinese to english: "the equipment department found that when the large package was opened, suspected mildew was found on the appearance of part of the package.A total of 2 goods were admitted to hospital this time.Among them, most of the packages were glued to each other, and there were many black spots on the outside.".

• Brand Name: BD SYRINGE WITH NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 10336353
• MDR Text Key: 202217226
• Report Number: 3002682307-2020-00231
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301940
• Device Lot Number: 1906102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other