MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SAFETYGLIDE SYRINGE

Catalog Number UNKNOWN

Device Problems Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 03/11/2021

Event Type  Injury  

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 in and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as the material and lot numbers were unknown for this incident and samples were unavailable for return, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that unspecified bd safetyglide syringe experienced 23 cases of infection, and 19 cases of foreign matter in device cannula/needle/syringe or any fluid path component.It has not been specified whether medical intervention was applied as a result of the infection.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via survey response that the clinician experienced leakage (12), bloodstream infection (blood stream bacteraemia, sepsis etc.) (23), syringe needle connectivity issue (21), foreign matter in fluid path (19).Additional information related to what leaked and from where states: "glucose" "needle".Additional information related to leakage ae: "fluid dropping".Additional information related to infection ae: "blood infiltration".

Event Description

It was reported that unspecified bd safetyglide syringe experienced 23 cases of infection, and 19 cases of foreign matter in device cannula/needle/syringe or any fluid path component.It has not been specified whether medical intervention was applied as a result of the infection.The following information was provided by the initial reporter: material no: unknown, batch no: unknown.It was reported via survey response that the clinician experienced leakage (12), bloodstream infection (blood stream bacteraemia, sepsis etc.) (23), syringe needle connectivity issue (21), foreign matter in fluid path (19).Additional information related to what leaked and from where states: "glucose" "needle".Additional information related to leakage ae: "fluid dropping".Additional information related to infection ae: "blood infiltration".

Manufacturer Narrative

H.6.Investigation: as the material and lot numbers were unknown for this incident and samples were unavailable for return, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Dhr could not be performed due to unknown lot#.The complaint could not be confirmed and the root cause is undetermined.

• Brand Name: UNSPECIFIED BD SAFETYGLIDE SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11646070
• MDR Text Key: 255137622
• Report Number: 2243072-2021-01065
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• 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
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other