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

Catalog Number 328822

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 08/25/2022

Event Type  malfunction  

Event Description

It was reported that 10 bd ultra-fine¿ ii short needle insulin syringes were missing their needles.The following information was provided by the initial reporter: "when the client pulled off the cap from multiple syringes they noticed that the needles are.Missing".

Manufacturer Narrative

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 10 bd ultra-fine¿ ii short needle insulin syringes were missing their needles.The following information was provided by the initial reporter: "when the client pulled off the cap from multiple syringes they noticed that the needles are.Missing".

Manufacturer Narrative

H6: investigation summary customer returned 7 used 0.3ml syringes and 2 polybags containing a total of 20 unused 0.3ml syringes from lot 1228497.Each of the used syringes feature some degree of damage to their needles.All needles are bent to varying degrees and some have fractured partway down the length of the needle, likely due to the stresses from the severe bending.The likely cause of this damage is high stresses applied to the needle during use or catching on the inside of the needle shield during reshielding.All of the 20 syringes from the unopened bags are in good condition.No damage or defects found.A review of the device history record was completed for batch# 1228497.All inspections and challenges were performed per the applicable operations qc specifications.Based on the samples received, embecta found that the used syringes returned featured some broken needles.The root cause of the needles bending is most likely high stress applied to the needles either during use or reshielding.

• Brand Name: BD ULTRA-FINE¿ II SHORT NEEDLE 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: 15460497
• MDR Text Key: 300392925
• Report Number: 1920898-2022-00636
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908822015
• UDI-Public: (01)00382908822015
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care 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: 09/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 328822
• Device Lot Number: 1228497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2021
• 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