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

Catalog Number 326638

Device Problem Material Separation (1562)

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

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device lot # unknown.Medical device expiration date : unknown.Initial reporter zip code : (b)(6).A device evaluation is pending but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device manufacture date : unknown.

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 about needle/shield separation from the barrel when removing the orange shield.

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 about needle/shield separation from the barrel when removing the orange shield.

Manufacturer Narrative

H.6.Investigation: no samples were returned therefore the investigation was performed based on the photos provided.Two photos of one 0.3ml bd insulin syringe were provided.The customer reported about needle/shield separation from the barrel when removing the orange shield.The photos were examined, and it was observed that needle hub/shield assembly was not fully seated on the barrel tip.Due to the batch being unknown, no dhr review can be completed.Capa#1630423 was initiated.H3 other text : see h.10.

• Brand Name: SYRINGE 0.3ML 30GA 8MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11953604
• MDR Text Key: 257413472
• Report Number: 1920898-2021-00644
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

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: Lay User/Patient
• Device Catalogue Number: 326638
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1