MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD PET SYRINGES 1/2ML 12.7MM X 29G; PISTON SYRINGE

Model Number	323001
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no physical samples were received; the investigation was performed based on the photo provided.This is the 2nd complaint for the reported lot number.A review of the manufacturing records was performed and one non-conformance was raised in association with this type of event for this lot.The reported issue was observed and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
Event or Problem Description
It was reported 5 bd pet syringes 1/2ml 12.7mm x 29g had incorrect label information on them.The following information was provided by the initial reporter: "consumer reported finding 5 boxes with the label of exp date and manufacture date to be switched on boxes only not bags.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-02-07.H6: investigation summary: customer returned 5 empty shelf cartons for 0.5ml, 29 gauge, 12.7mm syringes from lot 1116597.Each of the labels for the lot, manufacture date, and expiration date feature the manufacture date (2021-06-01) switched with the expiration date (2026-05-31).A review of the device history record was completed for batch# 1116597.All inspections and challenges were performed per the applicable operations qc specifications.There was a notification for this issue and it was released for ¿use as is¿.Based on the samples received, bd was able to confirm the customer¿s indicated failure of manufacturing/expiration date misprints.
Event or Problem Description
It was reported 5 bd pet syringes 1/2ml 12.7mm x 29g had incorrect label information on them.The following information was provided by the initial reporter: "consumer reported finding 5 boxes with the label of exp date and manufacture date to be switched on boxes only not bags.".

• Brand Name: BD PET SYRINGES 1/2ML 12.7MM X 29G
• 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: 13257639
• Report Number: 1920898-2021-01405
• Device Sequence Number: 14637876
• Product Code: FMF
• UDI-Device Identifier: 00382903230013
• UDI-Public: 00382903230013
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/11/2022

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: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: 323001
• Device Catalogue Number: 323001
• Device Lot Number: 1116597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• 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