MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE WALGREENS THIN INSULIN SYRINGES; PISTON SYRINGE

Model Number	928858
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 80 walgreens thin insulin syringes experienced scale marking issues.The following information was provided by the initial reporter: consumer reported scale markings are tilted and not straight on most all from this box.Counted 80 syringe.Using on dog with small amounts of insulin.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 07-mar-2022.H.6.Investigation: customer returned a total of (25) 0.3ml syringes with no other identification.Each of the syringes was inspected while referencing the position of their graduation markings.The location of the markings were all found to be within specifications.None of the markings were found to tilt significantly, and none were found to deviate in a manner that would place the markings outside of specification.A review of the device history record was completed for batch# 1081081.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that did not pertain to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed.
Event or Problem Description
It was reported that 80 walgreens thin insulin syringes experienced scale marking issues.The following information was provided by the initial reporter: consumer reported scale markings are tilted and not straight on most all from this box.Counted 80 syringe.Using on dog with small amounts of insulin.

• Brand Name: WALGREENS THIN INSULIN SYRINGES
• Common Device Name: 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: 13664362
• Report Number: 1920898-2022-00140
• Device Sequence Number: 4893565
• Product Code: FMF
• UDI-Device Identifier: 00311917048154
• UDI-Public: 00311917048154
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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
• Operator of Device: Other
• Device Expiration Date: 04/30/2026
• Device Model Number: 928858
• Device Catalogue Number: 928858
• Device Lot Number: 1081081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown