MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML LL NEEDLE 23G 1IN REGULAR BEVEL TW; PISTON SYRINGE

Catalog Number	309571
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Initial reporter state: address information was not able to be obtained, therefore, nj was used as a place holder.H.3.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 prior to use with bd 3ml ll needle 23g 1in regular bevel tw the shipper label was missing a barcode and the lot number and expiration date.The following information was provided by the initial reporter: customer discovered a potential product quality issue with syr+ndl ll bd 3ml 23gx1 100 (dev 04013).Customer discovered some of the boxes only had one bar code located on the box and others had two.Picture received also shows that lot and exp date are missing.
Additional Manufacturer Narrative
H6: investigation summary: one photo of a 3ml luer-lock syringe box carton was received and evaluated.The image shows two box cartons, both having box labels on the carton with one label having all applicable product information and the other label missing the secondary bar code, batch number and expiration date.The condition observed is non-conforming per product specification.Potential root cause for the label content missing defect is associated with the packaging process.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 prior to use with bd 3ml ll needle 23g 1in regular bevel tw the shipper label was missing a barcode and the lot number and expiration date.The following information was provided by the initial reporter: customer discovered a potential product quality issue with syr+ndl ll bd 3ml 23gx1 100 (dev 04013).Customer discovered some of the boxes only had one bar code located on the box and others had two.Picture received also shows that lot and exp date are missing.

• Brand Name: BD 3ML LL NEEDLE 23G 1IN REGULAR BEVEL TW
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17339256
• Report Number: 1213809-2023-00736
• Device Sequence Number: 6903380
• Product Code: FMF
• UDI-Device Identifier: 00382903095711
• UDI-Public: 00382903095711
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• 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): 08/22/2023

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: 309571
• Device Lot Number: 2318559
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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