MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 6MM; PISTON SYRINGE

Catalog Number 324912

Device Problems Defective Device (2588); Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 3 syringe 1.0ml 31ga 6mm had product damaged or foreign matter on the device.The following information was provided by the initial reporter :   the consumer reported that the plunger was damaged with the flanges were broken off and foreign matter was on the tip of the needles.  date of event: unknown.Samples: yes cl.

Event Description

It was reported that 3 syringe 1.0ml 31ga 6mm had product damaged or foreign matter on the device.The following information was provided by the initial reporter: the consumer reported that the plunger was damaged with the flanges were broken off and foreign matter was on the tip of the needles.Date of event: unknown; samples: yes cl.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-07-13.H6: investigation summary customer returned (4) 1cc, 6mm, 31g syringes in an open poly bag from lot # 0342354.Customer states that foreign matter was on the tip of the needle.All returned syringes were examined and one sample exhibited a small piece of orange material on the cannula shaft.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely polyethylene.Customer states that the flanges were broken off.All returned syringes were examined and one sample exhibited a broken flange.Customer states that the plunger was damaged.All returned syringes were examined and no defects were observed on the plungers of any of the samples.A review of the device history record was completed for batch# 0342354.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was not able to duplicate or confirm the customer¿s indicated failure the plunger was damaged.Bd was able to confirm the customer¿s indicated failure the flanges were broken off and foreign matter was on the tip of the needle.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: SYRINGE 1.0ML 31GA 6MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12132151
• MDR Text Key: 263389168
• Report Number: 1920898-2021-00728
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324912
• Device Lot Number: 0342354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1