MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 1ML SAFETYGLIDE¿ WITH ATTACHED NEEDLE; PISTON SYRINGE

Model Number	305903
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to use with 7 bd 1ml safetyglide¿ with attached needle the labeling information was missing on the wrapper.The following information was provided by the initial reporter: in this box i have found 7 syringe/needle packages that are sealed but the wrapper has no labeling information on it.It is completely blank.
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: medical device type: fmi.Common device name: hypodermic single lumen needle.Pma / 510(k)#: k951254 (needle).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: d10: device available for eval yes.D10: returned to manufacturer on: 28-mar-2023.H6: investigation summary: five sealed samples and one photo were provided to our quality team for investigation.Through visual inspection, it was observed that packages were missing all the top web graphics and applicable information.Potential root cause for the missing print defect is associated with the packaging process.This defect could occur if the camera looking for the unique device identifier (udi) graphics was not functioning properly.As corrective actions, work instruction and process control form will be updated to include a verification challenge once per shift to ensure the camera is functioning properly.A device history record review was completed for provided lot number 0254270.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.H3 other text : see h10.
Event or Problem Description
It was reported that prior to use with 7 bd 1ml safetyglide¿ with attached needle the labeling information was missing on the wrapper.The following information was provided by the initial reporter: in this box i have found 7 syringe/needle packages that are sealed but the wrapper has no labeling information on it.It is completely blank.

• Brand Name: BD 1ML SAFETYGLIDE¿ WITH ATTACHED NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16502856
• Report Number: 1213809-2023-00167
• Device Sequence Number: 6297623
• Product Code: FMF
• UDI-Device Identifier: 30382903059035
• UDI-Public: (01)30382903059035
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• 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): 04/10/2023

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: 08/31/2025
• Device Model Number: 305903
• Device Catalogue Number: 305903
• Device Lot Number: 0254270
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2020
• 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