MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 3 BD 0.3 ML SYRINGE; PISTON SYRINGE

Catalog Number 326631

Device Problem Volume Accuracy Problem (1675)

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

Event Date 12/24/2021

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 3 bd 0.3 ml syringes experienced issues with scale marking.The following information was provided by the initial reporter: non-biological (ink smears) ×3.

Manufacturer Narrative

H6: investigation summary.No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 1116769.All inspections were performed per the applicable operations qc specification.There was one (1) notification noted for missing print.

Event Description

It was reported that 3 bd 0.3 ml syringes experienced issues with scale marking.The following information was provided by the initial reporter: non-biological (ink smears) ×3.

Event Description

It was reported that 3 bd 0.3 ml syringes experienced issues with scale marking.The following information was provided by the initial reporter: non-biological (ink smears) ×3.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-02-08.H6: investigation summary: customer returned a total of (13) 0.3ml, 29 gauge, 12.7mm syringes from lot 1116769.The samples were separated in an unopened polybag with 7 units, an opened polybag with 5 units, and a single syringe in a plastic bag.Visual inspection of the syringes found no smudged graduation markings or text.All syringes are legible with no defects to their markings.A review of the device history record was completed for batch # 1116769 all inspections were performed per the applicable operations qc specifications.There was one (1) notifications noted for missing print.Based on the samples received, bd was unable to confirm the customer¿s indicated failure of smudged printing again.Root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: 3 BD 0.3 ML SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13290938
• MDR Text Key: 284524119
• Report Number: 1920898-2022-00006
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2022

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: Other
• Device Catalogue Number: 326631
• Device Lot Number: 1116769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/24/2021
• Initial Date FDA Received: 01/19/2022
• Supplement Dates Manufacturer Received: 01/20/2022; 02/14/2022
• Supplement Dates FDA Received: 02/01/2022; 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1