MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETY-GLIDE¿ INSULIN SYRINGES; PISTON SYRINGE

Catalog Number 305935

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/16/2023

Event Type  Injury  

Event Description

It was reported while using bd safety-glide¿ insulin syringes the safety mechanism spun freely.This is report 4 of 4.There was no report of patient impact.The following information was provided by the initial reporter: the bd syringes safety getting stuck during the activation process and increasing the risk and occurrence of needle sticks.Additional info received on 09-june-23.Are you able to describe more on the incident? staff are getting stuck during the activation process, this occurred 3 times in the first quarter of this year.When staff are activating the safety device, the safety device is not stationary¿it can actually do a 360 degree rotation.This rotation has resulted in staff being stuck by the needle because it will rotate during the activation of the safety mechanism.- are you able to provide lot number and product number of the defective roduct? no, i don¿t know for sure if the product is defective.I grabbed a handful of syringes from our med surg unit they lot numbers are 2308788 (a, b, c, d, e).However this incidents have taken place since the beginning of 2023 so i would said it impacts more than the lot noted above.Do you have the defective product to send to bd for investigation? if yes could you please provide shipping detail for us to send return label.No, see the second bullet.We do not have the actual devices rns have been injured on, but i have the handful of syringes i have pulled that have the same issues of the rotating safety mechanism.I am happy to return some new devices for review.Are you able to provide photo of the defective item? no, not of the actual syringes of the ones that stuck our staff.Do you have the date of event? can you give the date of the events? (b)(6) 2022, (b)(6) 2023.

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

• Brand Name: BD SAFETY-GLIDE¿ INSULIN SYRINGES
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17239566
• MDR Text Key: 318272179
• Report Number: 1920898-2023-00421
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305935
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention