MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA; INTRAVASCULAR CATHETER

Catalog Number	383312
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
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 bd saf-t-intima tubing was defective / damaged the following information was provided by the initial reporter: 1.Specific operation and use: on (b)(6) 2024, the patient in the department of infectious hepatology was given an indwelling needle in the left upper limb vein because intravenous infusion was needed for treatment, and on the morning of (b)(6) 2024, the nurse in the department found that there was a rupture and leakage in the clamp of the indwelling needle clamp before the infusion 2.Adverse events: leakage due to rupture of indwelling needle hose 3.Impact on the victim: no symptoms such as redness, swelling, heat and pain were observed at the patient's puncture opening, and no harm was caused for the time being.4.Treatment measures and results: the indwelling needle should be removed immediately, the puncture port should be disinfected after compression, and adverse events should be reported.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
A device history record review was completed by our quality engineer team for provided material number 383312 and lot number 2118822.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.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.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 SAF-T-INTIMA
• Common Device Name: INTRAVASCULAR CATHETER
• 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: 18768242
• Report Number: 9610847-2024-00037
• Device Sequence Number: 14577694
• Product Code: FOZ
• UDI-Device Identifier: 30382903833123
• UDI-Public: (01)30382903833123
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K923702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 383312
• Device Lot Number: 2118822
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown