MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problems Excess Flow or Over-Infusion (1311); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 02/27/2022

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 unspecified bd¿ syringe had difficult plunger movement.Additionally, the dexmedetomidine infused a full 3ml when only.5ml should have been infused.The following information was provided by the initial reporter: "event 1: date of event: (b)(6) 2022 @ 03:00.Description of event: channel did not have the total amount infused visible at 03:00.Patient injury: no.Model/brand and size of syringe: bd 60ml syringe.If a syringe malfunction, what channel: d.Medication being infused and rate/total volume: dexmedetomidine, rate: 0.2mls/hr, total volume should have been 0.8mls.Was there additional medical intervention to the patient: switched to different channel on different brain."it infused a full 3ml when it should have infused.5ml is all i know.".

• Brand Name: UNSPECIFIED BD¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13862118
• MDR Text Key: 289097481
• Report Number: 2243072-2022-00375
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• 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
• Patient Age: 2 DA
• Patient Sex: Male
• Patient Weight: 3 KG