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

Catalog Number 307731

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 07/22/2022

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using the bd emerald¿ syringe the tip of the syringe is broken off on the at injection point the following information was provided by the initial reporter, translated from dutch to english: the tip of the syringe is broken off on the at injection point.

Manufacturer Narrative

H.6.Investigation summary: a device history record review was completed for provided material number 307731 and lot number 2204148.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for this incident, twenty retained samples were obtained for evaluation; however, no signs of defect were found in the retained samples.An exact cause could not be determined for this incident.The material used to manufacture the emerald syringes has been selected and tested to resist normal conditions of use.The assembly machines have an in-line detection system that inspects all product and automatically rejects any damages identified.Based on these preventive measures, we believe it is possible that the reported incident resulted from a blockage during the barrel feeding process.After that, the damaged tip of the syringe went undetected during assembly and resulted in breakage.H3 other text : see h.10.

Event Description

It was reported that while using the bd emerald¿ syringe the tip of the syringe is broken off on the at injection point.The following information was provided by the initial reporter, translated from dutch to english: the tip of the syringe is broken off on the at injection point.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15287247
• MDR Text Key: 300448163
• Report Number: 3002682307-2022-00219
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 307731
• Device Lot Number: 2204148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2022
• 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