MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 328447

Device Problem Component Missing (2306)

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

Event Date 08/12/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter name and address: the customer's address is unknown.(b)(6) has been used as a default.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 safetyglide¿ insulin syringe was missing the thumb press tab.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: we have a decent number of insulin syringes in h20 that are missing the tab at the end of the plunger to help draw it back.

Event Description

It was reported that the bd safetyglide¿ insulin syringe was missing the thumb press tab.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "we have a decent number of insulin syringes in h20 that are.Missing the tab at the end of the plunger to help draw it back.".

Manufacturer Narrative

H6: investigation summary: customer returned an image of 0.5ml, 31 guage, 6mm sg syringe from lot 1343773, cat # 328447.The image shows the plunger rod is missing its thumbpress.The damage at the base of the plunger rod suggests it may have been cut or broken off.A review of the device history record was completed for batch# 1343773.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was able to confirm the customer¿s indicated failure.A definitive root cause cannot be determined.H3 other text : see h10.

• Brand Name: BD SAFETYGLIDE¿ INSULIN SYRINGE
• 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 ; 8015296192
• MDR Report Key: 15368403
• MDR Text Key: 301939052
• Report Number: 1920898-2022-00606
• 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,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328447
• Device Lot Number: 1343773
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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