MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SYRINGE 1ML ST BULK CONVENIENCE PAK

Catalog Number	309701
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd syringe 1ml st bulk convenience pak label content incorrect.It was reported by customer that the differences between the labeling on the box vs.The labeling on the outside of the tray packaging vs.The lot and expiration date on the coc.Rcc received a complaint via email.Customer is having issues with the differences between the labeling on the box vs.The labeling on the outside of the tray packaging vs.The lot and expiration date on the coc.Can you please correct the coc to reflect the lot number and expiration date 11/30/2028 and send it back to me? customer cannot use this product due to the discrepancy.This is a medical device and all the information must match.Please advise if you can update the coc.Thanks.Product number - 309701.Lot number - 4149225.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 309701 and lot number 4149225.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SYRINGE 1ML ST BULK CONVENIENCE PAK
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21102759
• Report Number: 9610847-2024-00409
• Device Sequence Number: 15617640
• Product Code: FMF
• UDI-Device Identifier: 30382903097013
• UDI-Public: (01)30382903097013(11)240613(17)290430(10)4149225
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: Health Professional
• Device Catalogue Number: 309701
• Device Lot Number: 4149225
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown