MAUDE Adverse Event Report: BD SUZHOU (MDS) SAF-T-INTIMA; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	383323
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that they have had 1 of these catheters that had a tiny shaving of metal attached to the tip of the needle that could easily break off.It appears to be an extra shaving/sliver that wasn¿t removed when the bevel was manufactured.Verbatim: complaint via email.Email(s) attached i wanted to report an issue with the bd saf-t-intima 22g iv catheter, lot 5259038.We have had 1 these catheters that had a tiny shaving of metal attached to the tip of the needle that could easily break off.It appears to be an extra shaving/sliver that wasn¿t removed when the bevel was manufactured.We were able to catch this prior to any patient use, and we have opened other catheters within this same lot and they have been ok so far.It was very difficult to get a good photo due to how small this shaving is but, hopefully this is helpful.Additional information received on 24-mar-2026: 1.Can you please provide an exact date of event in format dd-mmm-yyyy? this was discovered on 3/17/26.2.Can you share any physical sample if available for investigation? i still have the iv catheter intact that could be used as a physical example.3.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No serious event as this was caught prior to any patient use.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: SAF-T-INTIMA
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24766466
• Report Number: 3006948883-2026-00242
• Device Sequence Number: 18430145
• Product Code: FOZ
• UDI-Device Identifier: 00382903833238
• UDI-Public: (01)00382903833238(17)290831(10)5259038
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• 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): 05/01/2026

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: 383323
• Device Lot Number: 5259038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown