MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305917
Medical Device Problem Codes	Illegible Information (4050); Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd safetyglide¿ needle did not have a complete printing of the expiration date on the label, as well as other printed information on it being blurred.This occurred with 2700 needles.The following information was provided by the initial reporter, translated from chinese: "incomplete printing of the expiration date on the outer package label, and blurred printing of some font information such as qr code.".
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: five photos were provided to our quality team for investigation.One image shows the word "lot" surrounded by the box with the bottom line missing from the box.Second image shows the letters in the bd name and address slightly blurred; however, the wording is legible to read.These two conditions are acceptable per product specification.Third image shows a package with the expiration date cut-off with the day missing.Forth image shows the two-dimensional bar code with blurred print.Last image shows a web strip of five packages missing product label information.The conditions observed are non-conforming per product specification.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.H3 other text : see h10.
Event or Problem Description
It was reported that the bd safetyglide¿ needle did not have a complete printing of the expiration date on the label, as well as other printed information on it being blurred.This occurred with 2700 needles.The following information was provided by the initial reporter, translated from chinese: "incomplete printing of the expiration date on the outer package label, and blurred printing of some font information such as qr code.".

• Brand Name: BD SAFETYGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17552945
• Report Number: 1213809-2023-00866
• Device Sequence Number: 20574811
• Product Code: FMI
• UDI-Device Identifier: 00382903059171
• UDI-Public: 00382903059171
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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 Catalogue Number: 305917
• Device Lot Number: 2131673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• 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