MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 6MM; PISTON SYRINGE

Catalog Number 324909

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the syringe 0.3ml 31ga 6mm experienced no label or missing label inforamation.The following information was provided by the initial reporter: material no:324909 batch no: 3205282 customer called and stated the syringes they have in their possession have no expiration date listed, the syringes were received in bags (10syringes per bag) and she is trying to determine the expiration date.

Event Description

It was reported that the syringe 0.3ml 31ga 6mm experienced no label or missing label inforamation.The following information was provided by the initial reporter: material no:324909 batch no: 3205282.Customer called and stated the syringes they have in their possession have no expiration date listed, the syringes were received in bags (10syringes per bag) and she is trying to determine the expiration date.

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being manufactured in 2013 and files are retained for 7 years, no dhr review can be completed.H3 other text : see h.10.

• Brand Name: SYRINGE 0.3ML 31GA 6MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11377988
• MDR Text Key: 233492680
• Report Number: 1920898-2021-00222
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 324909
• Device Lot Number: 3205282
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1