MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALRG SFTYGLD 1ML W/NDL 26X3/8 IB; PISTON SYRINGE

Catalog Number	305951
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2021
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 syringe alrg sftygld 1ml w/ndl 26x3/8 ib came with a mix of product types in a pack.The following information was provided by the initial reporter: material no: 305951 batch no: 0141098.It was reported we are still finding the insulin syringes in sterile boxes daily.Verbatim: we opened the boxes on 1/15/2021.We are still finding the insulin syringes in sterile boxes daily.No one was injured.I had to throw away some of the needles as we had contaminated the needles with serum.
Additional Manufacturer Narrative
H6: investigation summary: 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# 0141098.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.H3 other text : see h10.
Event or Problem Description
It was reported that syringe alrg sftygld 1ml w/ndl 26x3/8 ib came with a mix of product types in a pack.The following information was provided by the initial reporter: material no: 305951.Batch no: 0141098.It was reported we are still finding the insulin syringes in sterile boxes daily.Verbatim: we opened the boxes on 1/15/21.We are still finding the insulin syringes in sterile boxes daily.No one was injured.I had to throw away some of the needles as we had contaminated the needles with serum.

• Brand Name: SYRINGE ALRG SFTYGLD 1ML W/NDL 26X3/8 IB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11317334
• Report Number: 1920898-2021-00183
• Device Sequence Number: 16783051
• Product Code: MEG
• UDI-Device Identifier: 00382903059515
• UDI-Public: 00382903059515
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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: Other
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 305951
• Device Lot Number: 0141098
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 02/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1