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

Catalog Number 324826

Device Problem Material Separation (1562)

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone# : (b)(6).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.

Event Description

It was reported that 1 syringe 0.3ml 30g 8mm hub separated.The following information was provided by the initial reporter : the distributor reported that when the protective cap is removed from the syringe the attached needle is also removed.This issue was identified on (b)(6) 2021.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-08-24.H6: investigation summary: customer returned (4) loose 3/10cc, 8mm, 30g syringes with the shelf carton from lot # 0090628.Customer states that when the protective cap is removed from the syringe, the attached needle is also removed.All returned syringes were examined and 3 out of 4 samples exhibited the hub-needle/shield assembly separated from the barrel.No defects were observed on the remaining sample.A review of the device history record was completed for batch# 0090628.All inspections and challenges were performed per the applicable operations qc specifications.There were three (3) notifications noted that did not pertain to the complaint.Bd was able to confirm the customer¿s indicated failure ub-needle/shield assembly separated from the barrel.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.Capa pr1630423 has been opened to address this issue.H3 other text : see h10.

Event Description

It was reported that 1 syringe 0.3ml 30g 8mm hub separated.The following information was provided by the initial reporter : the distributor reported that when the protective cap is removed from the syringe the attached needle is also removed.This issue was identified on (b)(6) 2021.

• Brand Name: SYRINGE 0.3ML 30G 8MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12242685
• MDR Text Key: 265180858
• Report Number: 1920898-2021-00829
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

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: 324826
• Device Lot Number: 0090628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 08/29/2021
• Supplement Dates FDA Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1