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	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 5ml ll syringe only mx bun packaging had discoloration / variation in color / cloudy.The following information was provided by the initial reporter translated from spanish to english: syringes with primary packaging with yellow coloration are being found during manufacturing, so we are not sure that this material is in conditions to be used, because our customers do not have the confidence to use this material.Additional information received on 04nov2024 ¿ the following dates of occurrence are reported in the previous email: october 23, 25, and 26.Could you please help us fill out the table below, including the respective quantities identified with respect to the defect for each of the dates? date lot quantity, pcs october 23 - - october 25 - - october 26 2098020 494 ¿ could you share photos for batch materials 2098020? phots added in attachments.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Ten samples and photos received by our quality team for investigation.Through visual inspection, the primary packaging is yellow, therefore the incident is confirmed.No other defects or issues observed on the product.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.Possible root cause is associated with the raw material.Visual inspections will be implemented.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Additional information ¿ we noticed you continue to report different batches for the same defect from 10/28.Could you please confirm if the material is being used in-line or if you are carrying out 100% sampling? a: the material is from the line and it does not receive a 100% inspection, as the staff is conditioning it, they notice that the blister has a different color and this separates the material with the defect.¿ additionally, please confirm if you find the defect when removing the syringes from the bd box or are the syringes being stored somewhere after removing them from the bd boxes? a: the material is not stored outside the bd boxes, it is removed from the boxes when it is going to be used for manufacturing.Additional information received on nov 19, 2024: ¿ could you please inform us what is the average manufacturing time of your batches? a: the average manufacturing time for our batches is 20 hours.

• 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: 20766963
• Report Number: 9614033-2024-00083
• Device Sequence Number: 9494028
• Product Code: FMF
• UDI-Device Identifier: 07501073025530
• UDI-Public: (01)07501073025530(11)220616(17)270331(10)2098020
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: 10/29/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/23/2024
• Supplement Report FDA Received Date: 12/12/2024
• 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