MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II INSULIN SYRINGE 3/10ML; PISTON SYRINGE

Catalog Number 320440

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 04/04/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd ultra-fine¿ ii insulin syringe 3/10ml the plunger was loose.There was no report of patient impact.The following information was provided by the initial reporter: one of the customer send me this complaint of her team of injectors about the bd syringe # 320440.For some time now, our professionals have noticed that the plunger is looser and the needle of poor quality.

Event Description

It was reported while using bd ultra-fine¿ ii insulin syringe 3/10ml the plunger was loose.There was no report of patient impact.The following information was provided by the initial reporter: one of the customer send me this complaint of her team of injectors about the bd syringe # 320440.For some time now, our professionals have noticed that the plunger is looser and the needle of poor quality.

Manufacturer Narrative

H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: BD ULTRA-FINE¿ II INSULIN SYRINGE 3/10ML
• 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: 16804324
• MDR Text Key: 313906239
• Report Number: 1920898-2023-00255
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

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: Other
• Device Catalogue Number: 320440
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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