MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM; PISTON SYRINGE

Catalog Number 328468

Device Problem Leak/Splash (1354)

Patient Problem Bruise/Contusion (1754)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is pending 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 0.5ml 31ga 8mm hub separated from the device.The following information was provided by the initial reporter : material no: 328468 batch no: 0022157.The consumer reported that when the needle shield was removed the needle hub separated.Date of event: (b)(6) 2021 , (needle hub separated on one 1 syringe).Samples: yes.

Event Description

It was reported that 1 bd syringe 0.5ml 31ga 8mm hub separated from the device.The following information was provided by the initial reporter : material no: 32846,8 batch no: 0022157, the consumer reported that when the needle shield was removed the needle hub separated.Date of event: 2021-04-28, (needle hub separated on one 1 syringe), samples: yes.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-05-24.H6: investigation summary: customer returned (2) 0.5ml bd insulin syringes in an opened polybag from lot# 0022157.Consumer reported some of the needles are "dull", and stated there was some bruising.Both returned samples were examined, and it was observed that 1 syringe exhibited needle hub/shield assembly separation.No damage to the barrel tip was observed.The other returned syringe was tested for visual inspection of point geometry, outer diameter and lube coverage (specs: outer diameter for 31g cannula: 0.0100¿- 0.0105¿), and it was observed that the cannula exhibited good point geometry, measured within the outer diameter specification at 0.0103¿, and had sufficient lubrication.No defects were observed.A review of the device history record was completed for batch# 0022157.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications noted that did not pertain to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure needle shield, needle hub separated.Capa pr1630423 has been opened to address this issue h3 other text : see h10.

• Brand Name: SYRINGE 0.5ML 31GA 8MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11894752
• MDR Text Key: 257434900
• Report Number: 1920898-2021-00607
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328468
• Device Lot Number: 0022157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1