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

Catalog Number 324919

Device Problem Complete Blockage (1094)

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

Event Date 10/17/2022

Event Type  malfunction  

Event Description

It was reported while using bd ultra-fine¿ insulin syringes the needles could not deliver the medication.There was no report of patient impact.The following information was provided by the initial reporter: i'm writing because we have been getting a number of faulty syringes in boxes over the past number of months.They have no take up ability when loading with insulin.So we have had to discard many.

Manufacturer Narrative

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

Manufacturer Narrative

H6: investigation summary no samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.The two images attached to this record is a picture of the back of the box which does not reflect the reported issue.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.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.A review of the device history record was completed for batch# 2066145.All inspection performed per the applicable operations qc specification.There were zero (0) notifications noted that pertained to the complaint.Embecta was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause cannot be determined at this time as the issue is unconfirmed as no samples were returned.

Event Description

It was reported while using bd ultra-fine¿ insulin syringes the needles could not deliver the medication.There was no report of patient impact.The following information was provided by the initial reporter: i'm writing because we have been getting a number of faulty syringes in boxes over the past number of months.They have no take up ability when loading with insulin.So we have had to discard many.

• Brand Name: BD ULTRA-FINE¿ 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 ; 8015296192
• MDR Report Key: 15782574
• MDR Text Key: 307098404
• Report Number: 1920898-2022-00790
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 324919
• Device Lot Number: 2066145
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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