MAUDE Adverse Event Report: BECTON DICKINSON BD EMERALD SYRINGE 2ML 24X1 AN; PISTON SYRINGE

Catalog Number 307749

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 08/18/2019

Event Type  malfunction  

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site."multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9036717.Medical device expiration date: 2024-01-31.Device manufacture date: 2019-02-05.Medical device lot #: 9058871.Medical device expiration date: 2024-02-29.Device manufacture date: 2019-02-27.(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 prior to use sharp molding defects were discovered with a bd emerald syringe 2ml 24x1 an.The following information was provided by the initial reporter: found defect product.

Event Description

It was reported that prior to use sharp molding defects were discovered with a bd emerald syringe 2ml 24x1 an.The following information was provided by the initial reporter: found defect product.

Manufacturer Narrative

H.6.Investigation summary: customer returned photograph shows the evidence of presence of damage component (plunger broken) on emerald syringe.Dhr was reviewed for the product test.No discrepancy was reported and recorded in dhr in customer reported lot # 9058871,9036717,9022583.The team reviewed the process controls of lot# 9058871,9036717,9022583 for primary & secondary packaging process.All process controls are in place and in working condition.Also, in process inspection and quality check, no broken plunger samples had been found.There are chances that during the primary packaging process plunger might got broke and get packed if in unit pack if the cutter air pressure is increased.The team has decided to put a control on the machine in the form of pressure sensor.This sensor will stop the machine if the air pressure is increased beyond 2.8 bar.With cutter air pressure = 2.8bar, if the part of the product comes in between the unit pack, the unit pack will not get separated and form as a continuous strip and will get rejected.H3 other text : see h.10.

• Brand Name: BD EMERALD SYRINGE 2ML 24X1 AN
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9087477
• MDR Text Key: 174737678
• Report Number: 2243072-2019-02070
• 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: 09/20/2019

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 Catalogue Number: 307749
• Device Lot Number: SEE H.10
• Initial Date Manufacturer Received: 08/25/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 08/25/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other