MAUDE Adverse Event Report: BD BD PRECISIONGLIDE NEEDLE 18G X 1 ½; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number REF 305196

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 02/03/2022

Event Type  malfunction  

Event Description

When removing syringe from wrapper under iso5 conditions, the pharmacy technician noted debris within the needle hub and did not use the product.Fda safety report id # (b)(4).

Event Description

When removing syringe from wrapper under iso5 conditions, the pharmacy technician noted debris within the needle hub and did not use the product.Fda safety report id # (b)(4).

Event Description

Additional information received from reporter on 3/25/2022 for report mw5107279; a 2022 report from ecri described a potential hazard where bd - 50 ml syringes may contain debris.According to the report, multiple pharmacy technicians have noticed the debris, but lot numbers were not recorded.This information was shared with pharmacy compounding personnel at healthcare.On "x/x/2022," pharmacy personnel at hospital of central (a healthcare facility) noticed debris in a bo - 10 ml syringe upon drawing up a medication.The debris was not seen in the vial prior to withdrawing, was seen in the syringe, and it was seen in the prepared final product which was then discarded.Wrapper and syringe were not saved.This information was shared across healthcare.This was reported to bd and fda medwatch.On "x/x/2022", pharmacy personnel at medical center (a healthcare facility) noticed debris in a bd 18 g 1 ½ in needle hub.The needle was not used for medication preparation.The syringe and over wrapper was saved.Product name: bo precisionglide needle 18g x 1 ½ ref 305196, lot 1120195.This information was shared across healthcare.This was reported to bo and fda medwatch.Communication related to the possibility of debris in sterile product equipment increased awareness and staff diligence prevented use of equipment with debris for the compounding of sterile medication.Circumstances or events have capacity to cause error.(b)(6).

• Brand Name: BD PRECISIONGLIDE NEEDLE 18G X 1 ½
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD
• MDR Report Key: 13479921
• MDR Text Key: 285458041
• Report Number: MW5107279
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF 305196
• Device Lot Number: LOT 1120195
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1