MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 31GA 8MM; PISTON SYRINGE

Catalog Number 320440

Device Problem Failure to Deliver (2338)

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

Event Date 09/01/2021

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 2 bd syringe 0.3ml 31ga 8mm had plunger issues and were unable to aspirate.The following information was provided by the initial reporter: the patient reported that for one of the syringes that when the plunger was pushed in it would not push down all the way and when tried to use the syringe to extract insulin, no insulin went into the syringe.Date of event: (b)(6) 2021.Samples: available.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-30.H6: investigation summary customer returned (2) loose 3/10cc, 8mm syringes.Customer states that syringe plunger would not push down all the way and no insulin went into the syringe when attempting to use it.Both returned syringes were examined and one sample exhibited the plunger rod separated from the stopper.The stopper was observed to be in the barrel backwards.The remaining sample was tested and was not able to draw properly.The sample was wired and the wire was not able to pass through the cannula, indicating there is an adhesive clog in the cannula.A review of the device history record was completed for batch# 0322848.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that did not pertain to the complaint.Bd was able to confirm the customer¿s indicated failure (adhesive clog).Bd was able to confirm the customer¿s indicated failure (stopper separates).Root cause: maintenance dispatch (l2l) was reviewed, and a dispatch l2l #113668 was created for stopper issues.The stoppers where not consistently going down the rail correctly and or falling out of the rail prior to assembly to the plunger.Correction: adjusted the pet (auto vibe) and balanced out the rail and bowl speed.In addition, cleaned the stopper rail.

Event Description

It was reported that 2 bd syringe 0.3ml 31ga 8mm had plunger issues and were unable to aspirate.The following information was provided by the initial reporter : the patient reported that for one of the syringes that when the plunger was pushed in it would not push down all the way and when tried to use the syringe to extract insulin, no insulin went into the syringe.Date of event : (b)(6) 2021 samples : available.

• Brand Name: BD SYRINGE 0.3ML 31GA 8MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12547109
• MDR Text Key: 273793550
• Report Number: 1920898-2021-01023
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320440
• Device Lot Number: 0322848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1