MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 30GA 8MM; PISTON SYRINGE

Catalog Number 326638

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/07/2021

Event Type  malfunction  

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 1 bd syringe 0.3ml 30ga 8mm hub separated from the device.The following information was provided by the initial reporter : the customer reported that the needle with the shield was separated from the barrel when removing the shield.

Manufacturer Narrative

Investigation summary: customer returned a several images of a polybag for 0.3ml, 30 gauge, 8mm syringes from lot 0286309.The needle hub has separated from the barrel of the syringe.A review of the device history record was completed for batch # 0286309 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the images received, bd was able to replicate or confirm the customer¿s indicated failure of a needle hub separation.Capa pr1630423 has been opened to address this issue.

Event Description

It was reported that 1 bd syringe 0.3ml 30ga 8mm hub separated from the device.The following information was provided by the initial reporter : the customer reported that the needle with the shield was separated from the barrel when removing the shield.

• Brand Name: BD SYRINGE 0.3ML 30GA 8MM
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12579596
• MDR Text Key: 275427595
• Report Number: 1920898-2021-01040
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K024112
• 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: 10/26/2021

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: 326638
• Device Lot Number: 0286309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• 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