MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1ML 31GX6MM U-100 INSULIN SYRINGE; PISTON SYRINGE

Model Number	328519
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.The customer's address is unknown:  new jersey (nj), usa has been used as a default.  a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the 1ml 31gx6mm u-100 insulin syringe experienced no label or missing label information.The following information was provided by the initial reporter: material no.328519, batch no.0223926.Pharmacy reported if items expired - no exp date on boxes.Unopened informed of manufacturing dates from lot #.Pharmacist thought it was recent date of event: (b)(6) 2021.
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 manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.A review of the device history record was completed for batch# 0223926.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.This was manufactured before expiration dates were printed on packaging.
Event or Problem Description
It was reported that the 1ml 31gx6mm u-100 insulin syringe experienced no label or missing label information.The following information was provided by the initial reporter: material no.328519 batch no.0223926.Pharmacy reported if items expired - no exp date on boxes.Unopened informed of manufacturing dates from lot #.Pharmacist thought it was recent.Date of event 03/25/2021.

• Brand Name: 1ML 31GX6MM U-100 INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11702295
• Report Number: 1920898-2021-00441
• Device Sequence Number: 3481437
• Product Code: FMF
• UDI-Device Identifier: 00681131138345
• UDI-Public: 00681131138345
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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 Model Number: 328519
• Device Catalogue Number: 328519
• Device Lot Number: 0223926
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1