MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 1.0ML 31G TW 6MM BLS 400 SG; PISTON SYRINGE

Catalog Number 328446

Device Problems Difficult or Delayed Activation (2577); Material Protrusion/Extrusion (2979)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

Unknown manufacturer: (b)(4).Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that a syringe 1.0ml 31g tw 6mm bls 400 sg experienced safety shield failure causing a needle stick during use.The following was reported by the initial reporter: "it was reported a needle stick injury and the entire safety device fell off.  event description states: i am not sure if you are the correct persons for me to report this to, however, we had another needle stick injury with the bd safetyglide insulin syringe ( safetyglide insulin syringe (1ml x 31g x 15/64¿).I know that one of my nurse educators did reach out to you and you shared educational literature.However, one of our nurses reported that when she went to engage the safety device after administering insulin, the entire safety device fell off (the white lever and cap) causing the puncture of her finger.The nurse was flustered after this event occurred, and did not think to try to save the syringe or take a photo -- she wanted to draw the appropriate post-exposure labs.".

Event Description

It was reported that a syringe 1.0ml 31g tw 6mm bls 400 sg experienced safety shield failure causing a needle stick during use.The following was reported by the initial reporter: "it was reported a needle stick injury and the entire safety device fell off.  event description states: i am not sure if you are the correct persons for me to report this to, however, we had another needle stick injury with the bd safetyglide insulin syringe ( safetyglide insulin syringe (1ml x 31g x 15/64¿).I know that one of my nurse educators did reach out to you and you shared educational literature.However, one of our nurses reported that when she went to engage the safety device after administering insulin, the entire safety device fell off (the white lever and cap) causing the puncture of her finger.The nurse was flustered after this event occurred, and did not think to try to save the syringe or take a photo -- she wanted to draw the appropriate post-exposure labs.".

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch number being unknown, no dhr review can be completed.H3 other text : see h.10.

• Brand Name: SYRINGE 1.0ML 31G TW 6MM BLS 400 SG
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11084462
• MDR Text Key: 227729260
• Report Number: 2243072-2020-02171
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 328446
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR