MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE; PISTON SYRINGE

Catalog Number 305950

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd allergy syringe tray with bd safetyglide¿ needle plunger broke off while being pushed during the injection.The following information was provided by the initial reporter: "on (b)(6) 2023 an rn attempted to administer a subcutaneous injection to a patient with bd safetyglide 1ml 27g 1/2 in allergy syringe.Once plunger was pushed, the plunger broke off.Rn needed to take the half broken plunger and insert it into the barrel of the syringe in order to continue to administer the injection, as the needle was still in the patient's arm.Did you experience any adverse events as a result of this reported defect? the initial notification stated that the plunger broke while in patient arm, was there any medication intervention required due to the defect? the patient received the complete dose of medication and luckily did not get injured.No other intervention was required".

Manufacturer Narrative

Investigation summary: two photos were received with the customer's complaint of broken syringe plunger.The second photo clearly shows the broken plunger and the complaint has been verified.Without further information, the root cause of the failure is unknown.A review of the device history record was completed for batch# 2304574.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.

Event Description

Photos received.

• Brand Name: BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE
• 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: 17075531
• MDR Text Key: 316691613
• Report Number: 1920898-2023-00336
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 00382903059508
• UDI-Public: 00382903059508
• 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,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305950
• Device Lot Number: 2304574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2022
• 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