MAUDE Adverse Event Report: BECTON DICKINSON 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	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported bd insyte yel 24ga x 0.75in was missing label content.The following information was provided by the initial reporter; when the product arrived at the hospital for inspection, it was found that the smallest individual package had no chinese label.
Event or Problem Description
When the product arrived at the hospital for inspection, it was found that the smallest individual package had no chinese label.
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 ¿it was found that the smallest individual package had no chinese label¿.However, upon review of the unit label graphics of the affected catalogue number 381212 (refer to figure 1 in attachment a) with bd document number (b)(4) revision 06, 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.H3 other text : see h10 manufacture narrative.

• Brand Name: 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 NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18035571
• Report Number: 2243072-2023-01972
• Device Sequence Number: 8277721
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 01/17/2024
• 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
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown