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

Catalog Number 328449

Device Problem Volume Accuracy Problem (1675)

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

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date : unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device manufacture date : unknown.

Event Description

It was reported that 1 bd syringe 0.3ml 31g tw 6mm had scale marking issues.The following information was provided by the initial reporter : the customer reported being unable to measure smaller doses that were measurable when 0.5 unit increments were displayed on syringe.

Event Description

It was reported that 1 bd syringe 0.3ml 31g tw 6mm had scale marking issues.The following information was provided by the initial reporter : the customer reported being unable to measure smaller doses that were measurable when 0.5 unit increments were displayed on syringe.

Manufacturer Narrative

H6: investigation summary no samples were returned therefore the investigation was performed based on the photos provided.Two photos of a loose 0.3ml bd insulin syringe were provided.The customer reported that they desire low dose insulin 30 unit syringe with 0.5 unit demarcations.The photos were examined, and it was observed that the scale markings could not be viewed due to the position of the syringe in the first photo provided.In the second photo it was observed that the syringe exhibited a half-unit scale marking.No defects were observed.Due to the batch being unknown no dhr review can be completed.Bd was not able to duplicate or confirm the customer¿s indicated failure based on the photos received.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.

• Brand Name: BD SYRINGE 0.3ML 31G TW 6MM
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12586567
• MDR Text Key: 275425487
• Report Number: 1920898-2021-01044
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 328449
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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