MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD SYRINGE 5ML LL SYRINGE ONLY MX BUN; PISTON SYRINGE

Catalog Number	302553
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe 5ml ll syringe only mx bun had a scale marking issue.The following information was provided by the initial reporter translated from spanish to english: during the inspection of inputs, in the functional test of division of the syringe, 2 pcs are detected out of values above the milliliter and in the sub division test 9 pcs above 0.2 mm and 4 below 0.2 mm.Our test is by weight considering the density of water as 1g/ml to validate the volume vs.The divisions and subdivisions of the syringe.The balance is calibrated and the tolerance is 4%.
Additional Manufacturer Narrative
Package received for investigation, however there were no samples inside.One photo received, through visual inspection, label of the collective box, confirming the code number (302553) and lot (2098020) reported was observed.No defects or issues observed.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Physical sample is required to further analyze.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.
Event or Problem Description
No additional information.

• Brand Name: BD SYRINGE 5ML LL SYRINGE ONLY MX BUN
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19767668
• Report Number: 9614033-2024-00051
• Device Sequence Number: 20983802
• Product Code: FMF
• UDI-Device Identifier: 07501073025530
• UDI-Public: (01)07501073025530
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K151766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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: 302553
• Device Lot Number: 2098020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown