MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGES, 1ML 30G X 1/2; PISTON SYRINGE

Model Number	329406
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.Initial reporter state: address information was not able to be obtained, however, nj was used as a place holder.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the expiration date was missing on shelf pack with a bd ultra-fine¿ insulin syringes, 1ml 30g x 1/2.The following information was provided by the initial reporter: it was reported that expiration date was not on shelf carton.Consumer wanted to know if syringes were still good to use.Stated, did not see expiration date.
Event or Problem Description
It was reported that the expiration date was missing on shelf pack with a bd ultra-fine¿ insulin syringes, 1ml 30g x 1/2.The following information was provided by the initial reporter: it was reported that expiration date was not on shelf carton.Consumer wanted to know if syringes were still good to use.Stated, did not see expiration date.
Additional Manufacturer Narrative
H.6.Investigation: 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# 6312688.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.This batch was manufactured before expiration dates were printed on packaging.

• Brand Name: BD ULTRA-FINE INSULIN SYRINGES, 1ML 30G X 1/2
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11387846
• Report Number: 1920898-2021-00243
• Device Sequence Number: 3443480
• Product Code: FMF
• UDI-Device Identifier: 00382903294060
• UDI-Public: 00382903294060
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 329406
• Device Catalogue Number: 329406
• Device Lot Number: 6312688
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1