MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD LOW-DOSE U-100 INSULIN SYRINGE WITH BD MICRO-FINE IV; INSULIN SYRINGE WITH NEEDLE

Catalog Number	329461
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd low-dose¿ u-100 insulin syringe with bd micro-fine¿ iv has scale marking issues.The following information was provided by the initial reporter: material no.: 329461.Batch no.: 8106971.The bevel of the needle is not aligned with the graduation on the syringe resulting in difficulty when doing an injection when they have to follow the graduation.Additionally, customer states the wrapping has changed.Verbatim: i received a complaint about the syringe 329461 saying that the wrapping has change but most important is that the bevel of the needle is not align with the graduation on the syringe and that is harder to do injection when they have to follow the graduation.
Event or Problem Description
It was reported that bd low-dose¿ u-100 insulin syringe with bd micro-fine¿ iv has scale marking issues.The following information was provided by the initial reporter: material no.: 329461 batch no.: 8106971 the bevel of the needle is not aligned with the graduation on the syringe resulting in difficulty when doing an injection when they have to follow the graduation.Additionally, customer states the wrapping has changed.Verbatim: i received a complaint about the syringe 329461 saying that the wrapping has change but most important is that the bevel of the needle is not align with the graduation on the syringe and that is harder to do injection when they have to follow the graduation.
Additional Manufacturer Narrative
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# 8106971.All inspections and challenges were performed per the applicable operations qc specifications.There were four (4) notifications [200767883, 200767661, 200767439, 200767835] noted that did not pertain to the complaint.

• Brand Name: BD LOW-DOSE U-100 INSULIN SYRINGE WITH BD MICRO-FINE IV
• Common Device Name: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8575511
• Report Number: 1920898-2019-00414
• Device Sequence Number: 1639243
• Product Code: FMF
• UDI-Device Identifier: 30382903294610
• UDI-Public: 30382903294610
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 329461
• Device Lot Number: 8106971
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other