MAUDE Adverse Event Report: BECTON DICKINSON BD EMERALD¿ SYRINGE WITH NEEDLE; PISTON SYRINGE

Catalog Number 302932

Device Problem Product Quality Problem (1506)

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

Event Date 12/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 the glue used to attach the bd emerald¿ syringe's needle and hub "overflows".

Manufacturer Narrative

H.6.Investigation summary: customer returned sample showed the presence of epoxy like white substance on the cannula as foreign matter.The team reviewed the customer returned samples and confirmed that foreign matter present on cannula of needle is white color substance which is likely to be epoxy.As per lot manufacturing records, no similar defect was reported during inspection incoming quality for 21g needle batch# 8087144 and assembly operations.Although these epoxy-like white substances can probably be added during the needle manufacturing process.As the needles are imported from (b)(4), hence need to investigate bd tuas manufacturing process for needle.The exact root cause could not be identified.The customer returned sample having the defect was sent to tuas plant for further investigation.The defect is confirmed.Complaints received for this device and the reported defect will continue to be tracked and trended.The information will be captured in the trend reports and monitored monthly.Collected data are regularly reviewed to identify emerging trends.Based on this, a capa is not needed at this time.Investigation from tuas: one photo and one actual sample in open package were returned for evaluation.10ml syringe is not produce in tuas plant.The returned sample was subjected to visual inspection.It was observed to have a white foreign matter on the hub of the needle.The white foreign matter is likely to be epoxy.Complaint history was reviewed.No similar complaints on this non-conformance were received for the reported manufacturing lot.Needle pn batch #8087144, an batch #8087095, dhr reviewed.No similar non-conformance was detected during in-process and outgoing inspection.No quality notification was raised on past 12 months on similar non-conformance.Needle pn batch #8087144, an batch #8087095, the preventive maintenance, calibration and machine history records were reviewed no abnormality was observed.Confirmed: able to duplicate or confirm the indicated failure mode.Excessive epoxy on the hub of the needles could happen when there is stoppages at the cannula station.The manufacturing process was reviewed.The production technician was supposed to remove the first rack once the machine started running again, to prevent hub with excessive flow to the next station.This action was not documented but communicated.The production technician may fail to remove the first rack and result in the nonconformance part flowing to the next process.Rationale for no capa: the product is manufactured before the improvement actions are implemented in 30 oct 2018.Action: to conduct awareness briefing to production technicians regarding on this reported non-conformance.Update of ojt for the assembly line troubleshooting for excessive epoxy to remove the first rack whenever there is a restart after cannulation station stoppage.

Event Description

It was reported that the glue used to attach the bd emerald¿ syringe's needle and hub "overflows".

• Brand Name: BD EMERALD¿ SYRINGE WITH NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8237872
• MDR Text Key: 132916319
• Report Number: 2243072-2018-01955
• 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: 03/12/2019

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: 04/30/2023
• Device Catalogue Number: 302932
• Device Lot Number: 18E2971
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 12/26/2018
• Supplement Dates FDA Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other