MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE YEL 24GA X 0.75IN; INTRAVASCULAR CATHETER

Catalog Number	381212
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte yel 24ga x 0.75in was missing the chinese label.Inserts discovered before use, there is no chinese label on the smallest individual package of the product, the number of affected 25 pcs, need a letter of response to the complaint, need a letter of acceptance of the complaint, need a green claim, the photo can not be provided, the sample can not be returned.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.Based on the verbatim, it was reported that ¿there is no chinese label on the smallest individual package of the product¿.However, upon review of the unit label graphics of the affected catalogue number 381212, it was observed that there was no chinese character on the unit label.Hence, the chinese label that was reported missing was most likely not part of tuas plant¿s original labelling.This non-conformance most likely occurred outside of tuas manufacturing facility.
Event or Problem Description
Discovered before use, there is no chinese label on the smallest individual package of the product, the number of affected 25 pcs, need a letter of response to the complaint, need a letter of acceptance of the complaint, need a green claim, the photo can not be provided, the sample can not be returned.

• Brand Name: BD INSYTE YEL 24GA X 0.75IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18446389
• Report Number: 2243072-2023-02278
• Device Sequence Number: 15445093
• Product Code: FOZ
• UDI-Device Identifier: 30382903812128
• UDI-Public: (01)30382903812128
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: 381212
• Device Lot Number: 1321083
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown