MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD EMERALD¿ SYRINGE; PISTON SYRINGE

Catalog Number 307736

Device Problems Fungus in Device Environment (2316); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

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.

Event Description

It was reported that moldy foreign matter was found on the unopened bd emerald¿ syringe.The following information was provided by the initial reporter: "unopened syringe is mouldy.".

Event Description

It was reported that moldy foreign matter was found on the unopened bd emerald¿ syringe.The following information was provided by the initial reporter: "unopened syringe is mouldy.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-10-14.H6: investigation summary a photo and the affected sample were received by our quality team for evaluation.After evaluation, the team was able to identify the foreign matter as embedded contamination in the syringe tip.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The team was able to determine that the black mark observed in the tip of the syringe is a defect regarding embedded particles in the plunger.The embedded particle defect was produced in the screw of the injection molding machine.Due to the high working temperature (about 300ºc), different gases are produced inside the mold.During normal production, these gases are expelled through some conduits, outside the mold cavity.In this case, the expulsion was not done correctly, and some gases remained in the mold cavity and produce the burnt syringe piece.H3 other text : see h10.

• Brand Name: BD EMERALD¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12624569
• MDR Text Key: 276174633
• Report Number: 3002682307-2021-00550
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 307736
• Device Lot Number: 2009140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1