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

Model Number	328506
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 or Problem Description
It was reported that a syringe 1.0ml 31ga 8mm 10bag 500 wal had incorrect label information before use.The following was reported by the initial reporter: "it was reported that the syringes are usually in a whit box, but this time they are in a green box.Verbatim: pharmacist reported typically the 31g, 8mm, 1ml syringes are in a white box.Stated he has a box labeled 31g, 8mm, 1ml syringes however they are in a green box which is typically for the 6mm syringes.Stated he is unsure if the correct syringes are in this box or if the box is mislabeled.Declined replacement.Lot # 0241664, cat # unknowndate of event: (b)(6) 2020, samples: yes, sending mail kit".
Event or Problem Description
It was reported that a syringe 1.0ml 31ga 8mm 10bag 500 wal had incorrect label information before use.The following was reported by the initial reporter: "it was reported that the syringes are usually in a whit box, but this time they are in a green box.Verbatim: pharmacist reported typically the 31g, 8mm, 1ml syringes are in a white box.Stated he has a box labeled 31g, 8mm, 1ml syringes however they are in a green box which is typically for the 6mm syringes.Stated he is unsure if the correct syringes are in this box or if the box is mislabeled.Declined replacement.Lot # 0241664cat # unknowndate of event: 12/28/20samples: yes sendig mail kit".
Additional Manufacturer Narrative
H6: investigation summary:# 0241664.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.H3 other text : see h10.

• Brand Name: SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11189878
• Report Number: 1920898-2021-00086
• Device Sequence Number: 11540922
• Product Code: FMF
• UDI-Device Identifier: 00681131311748
• UDI-Public: 00681131311748
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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 Expiration Date: 08/31/2025
• Device Model Number: 328506
• Device Catalogue Number: 328506
• Device Lot Number: 0241664
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 04/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1