MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD EMERALD¿ SYRINGE

Catalog Number 302981

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation conclusion: not confirmed: bd cannot confirm/reproduce the incident in question needle pulled out of hub.Samples/ photos analysis: neither sample nor picture sent by the customer, only retention sample analyzed.The batch in question was manufactured during march 4th 2016 to march 7th 2016.According to machine assembly maintenance records, it was checked for a performance adjustment.Moreover the procedures for detecting this kind of failure were done during whole shift.Maintenance review: there are no quality notifications (qn) in the maintenance records.The analysis of the batch history had no quality notifications found, only maintenance records.As neither picture nor sample were provided, bd analyzed internal retention sample.They were within specifications and consequently bd was not able to confirm the defect needle pulled out of hub.According the bd procedures, the hub cannula extract test was performed in 25 pieces every shift start.In case one defect is found the whole lot was rejected.In addition this scope will be monitored to evaluate any further occurrence.Root cause description: since neither sample nor picture was provided, unfortunately bd was not able to confirm the defect or determine the root cause.Rationale: based on severity and occurrence a capa is not required.

Event Description

It was reported that the needle of a bd emerald¿ syringe detached from the device and remained in the patient.The detached needle was removed with no reported medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: unknown.Event attributed to: other.Device single use?: no.Device returned to manufacture: no.

Event Description

It was reported that the needle of a bd emerald¿ syringe detached from the device and remained in the patient.The detached needle was removed with no reported medical intervention.

• Brand Name: BD EMERALD¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 7660613
• MDR Text Key: 113256238
• Report Number: 3003916417-2018-00144
• 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
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

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: 03/31/2021
• Device Catalogue Number: 302981
• Device Lot Number: 6067408
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 06/12/2018
• Supplement Dates FDA Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other