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

Catalog Number 326638

Device Problem Material Deformation (2976)

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

Event Date 03/13/2023

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

Hold js 3/30.It was reported that 5 bd ultra-fine¿ ii insulin syringes had deformed rubber stoppers.The following information was provided by the initial reporter, translated from japanese: "this is a report about the rubber stopper deformed.According to the user's report, the rubber stopper was found to be deformed.".

Manufacturer Narrative

H6: investigation summary the customer returned (5) 0.3ml 30g 8mm syringe reporting damaged stopper.The syringe was visually inspected.Upon visual inspection, embecta was not able to confirm the reported failure of stopper damage.Due to the batch being unknown, no dhr review can be completed.Based on the samples received, embecta was not able to confirm or duplicate the customer¿s indicated failure of damaged stopper.H3 other text : see h10.

Event Description

It was reported that 5 bd ultra-fine¿ ii insulin syringes had deformed rubber stoppers.The following information was provided by the initial reporter, translated from japanese: "this is a report about the robber stopper deformed.According to the user's report, the robber stopper was found to be deformed.".

• Brand Name: BD ULTRA-FINE¿ II 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 ; 8448235433
• MDR Report Key: 16640222
• MDR Text Key: 312356757
• Report Number: 1920898-2023-00169
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 326638
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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