MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SAFETYGLIDE SYRINGE

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007); Patient Device Interaction Problem (4001)

Patient Problems Bacterial Infection (1735); Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

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 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.Examination of the product involved may provide clarification as to the cause for the reported failure.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 12 cases of leakage, 2 cases of dirty needle stick injury, 1 case of bloodstream infection, 10 cases of clogged/blocked needles, 1 case of foreign matter contamination, and 8 cases of damaged/open unit packaging/seals where sterility was compromised.It has not been specified whether medical intervention was applied as a result of the dirty needle stick injuries.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 exposure to body fluid or blood (12), leakage (12), bloodstream infection (blood stream bacteraemia, sepsis etc.) (1), needlestick injury before use on patient (12), needlestick injury after use on patient (2), syringe needle connectivity issue (1), needle clogged (10), foreign matter in fluid path (1), foreign matter in packaging (4), package open before use / damaged packaging (8), needle dull (4), needle bent (5).Additional information related to the clinician's exposure to blood.: "an accidental puncture with clean and used needles." additional information related what leaked and from where states: "blood" "the needle system." additional information related to needlestick prior to use states: "a surface injury.".

• Brand Name: UNSPECIFIED BD SAFETYGLIDE SYRINGE
• Type of Device: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11635084
• MDR Text Key: 244945910
• Report Number: 2243072-2021-01020
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2021
• 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 Outcome(s): Other