MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS; PISTON SYRINGE

Model Number 328418

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 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.The customer's address is unknown.New (b)(6) usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a box of syringe 1.0ml 31ga 8mm ufii 10bag 500cs had missing label information before use.The following was reported by the initial reporter: it was reported that expiration date was not on the box.Verbatim: pharmacist called to inquire about syringe expiration.Stated that the expiration date was not on the box.

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# 7177597.All inspections were performed per the applicable operations qc specifications.This batch was manufactured before expiration dates were printed on packaging.There was one (1) notification [200703954] noted that did not pertain to the complaint.

Event Description

It was reported that a box of syringe 1.0ml 31ga 8mm ufii 10bag 500cs had missing label information before use.The following was reported by the initial reporter: "it was reported that expiration date was not on the box." verbatim: pharmacist called to inquire about syringe expiration.Stated "that the expiration date was not on the box.".

• Brand Name: SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11383153
• MDR Text Key: 234281195
• Report Number: 1920898-2021-00236
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908418034
• UDI-Public: 00382908418034
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

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 Model Number: 328418
• Device Catalogue Number: 328418
• Device Lot Number: 7177597
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1