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

Catalog Number 307736

Device Problem Inappropriate Audible Prompt/Feedback (2280)

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

Event Date 01/24/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the syringe pump alarm went off for occlusion while the bd emerald¿ syringe was in use.The following information was provided by the initial reporter: "issue with 10ml emerald syringes on bd alaris syringe driver at end of infusion it alarms occlusion instead of end of infusion.".

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the syringe pump alarm went off for occlusion while the bd emerald¿ syringe was in use.The following information was provided by the initial reporter: "issue with 10ml emerald syringes on bd alaris syringe driver at end of infusion it alarms occlusion instead of end of infusion.".

Manufacturer Narrative

H.6.Investigation: based on the provided feedback, our quality team understands that this incident was related to customer misuse and therefore, there is no bd related quality defect to investigate.Per the follow up communication, it appears the customer has been made aware of the compatible products to prevent further issue.Dhr could not be performed due to unknown lot#.

Event Description

It was reported that the syringe pump alarm went off for occlusion while the bd emerald¿ syringe was in use.The following information was provided by the initial reporter: "issue with 10ml emerald syringes on bd alaris syringe driver at end of infusion it alarms occlusion instead of end of infusion.".

• 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: 13459248
• MDR Text Key: 285334245
• Report Number: 3002682307-2022-00044
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 307736
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNSPECIFIED BD ALARIS SYRINGE DRIVER