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

Catalog Number 324914

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

The customer's name and address is unknown.(b)(6) has been used as a default.A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that when removing a bd insulin syringe with bd ultra-fine¿ needle from the package, the needle was bent in such a way that it went through the lid.There was no report of injury or medical interventions.

Manufacturer Narrative

Investigation results: investigation summary: customer returned a photo of a 1cc syringe.The returned photos were examined and exhibited scratches in the barrel.A review of the device history record was completed for batch# 7143987.All inspections were performed per the applicable operations qc specifications.There were four (4) notifications [200696635, 200696771, 200697235, 200696595] noted that did not pertain to the complaint.Severity: s1; occurrence: a complaint history check was performed and this is the 1st related complaint reported for the defect/condition on lot number 7143987.Based on the samples / photo(s) received the investigation concluded: - confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (scratched barrel) probable root cause: scratched barrel is due to syringe contacting a machine part during conveyance after printing.Based on the above, no additional investigation and no capa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7437477
• MDR Text Key: 105890830
• Report Number: 1920898-2018-00270
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 324914
• Device Lot Number: 7156932
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other