MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 5ML EMERALD BNS

Catalog Number 303127

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(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 different syringes were found with the syringes 5ml emerald bns during the packaging process.The customer reported 67733 occurrences of this event.The following information was provided by the initial reporter: i would like to inform you about new non-conformance that was detected at the beginning of the packaging process at our site.Inside the package with syringes p/n kz-03127-001 (bd p/n 303127), lot 71p19b0915 (bd batch 9029551) there were found 2 pieces of different syringe (pn unknown).

Manufacturer Narrative

Investigation: bd has been provided with a photo of catalog 303127 lot 9029551 to investigate for this record.The photo shows bd manufactured a n emerald 5ml syringe with a plunger of discardit 5ml syringe.As a result, bd was able to verify the reported issue.Although bd has established procedures and verification process for line-clearance; bd can conclude that one of those operations failed.Specifically, bd has confirmed that the machine operator by mistake activated the airway system used to feed the bd discardit plungers in the assembly process.Despite this human error, this should not have any consequence on the product because the bd discardit plunger feeder is emptied when manufacturing bd emerald syringes.Therefore, bd can conclude this issue has been originated because of a combination of both situations.A bhr was done for the affected batch and was confirmed to be released according to defined procedures and requirements.

Event Description

It was reported that different syringes were found with the syringes 5ml emerald bns during the packaging process.The customer reported 67733 occurrences of this event.The following information was provided by the initial reporter: i would like to inform you about new non-conformance that was detected at the beginning of the packaging process at our site.Inside the package with syringes p/n kz-03127-001 (bd p/n 303127), lot 71p19b0915 (bd batch 9029551) there were found 2 pieces of different syringe (pn unknown).

• Brand Name: SYRINGE 5ML EMERALD BNS
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8565160
• MDR Text Key: 143810779
• Report Number: 3002682307-2019-00277
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

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: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 303127
• Device Lot Number: 9029551
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other