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

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2022

Event Type  Injury  

Event Description

It was reported that unspecified bd xs syringe experienced 3 cases of air embolism, 3 cases of exposure to bloodborne pathogens, 1 case of infection, 1 case of leakage which led to hazardous drug or fluid exposure, 1 case of mucocutaneous blood exposure, 3 cases of particulate embolism, a case of sepsis infection, and a case of crbsi infection.The following information was provided by the initial reporter: reported air embolism, exposure to bloodborne pathogens, localized infection, leakage leading to hazardous drug / fluid exposure, mucocutaneous blood exposure, particulate embolism, sepsis, systemic infection/crbsi.

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.(b)(4).(b)(6).Medical device expiration date: unknown.Device manufacture date: unknown.Bd was unable to perform a thorough investigation as no item number, sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: UNSPECIFIED BD XS 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: 14556574
• MDR Text Key: 293072259
• Report Number: 2243072-2022-00747
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• 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: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention