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	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 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.
Event or Problem Description
Additional information we noticed you keep reporting different batches for the same defect on 10/28.Could you please confirm if the material is being used in line or if you are performing a 100% sampling? r: the material is in line and it does not receive a 100% inspection, as it is being conditioned the staff notices that the blister has a different color and this separates the material with the defect.Additionally, please confirm if you find the defect when you take the syringes out of the bd box or are you storing the syringes somewhere after taking them out of the bd boxes? r: the material is not stored outside the bd boxes; it is removed from the boxes when it is to be used for manufacturing.Could you please let us know what is the average manufacturing time of your batches? r: the average manufacturing time for our batches is 20 hours.
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.

• 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: 20855718
• Report Number: 9614033-2024-00086
• Device Sequence Number: 21004627
• Product Code: FMF
• UDI-Device Identifier: 07501073025530
• UDI-Public: (01)07501073025530(11)220623(17)270331(10)2098019
• 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: 2098019
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown