MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN; INTRAVASCULAR CATHETER

Catalog Number	383335
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a protruding bulge was found on the bd saf-t-intima¿ safety system with removable prn before use.The following information was provided by the initial reporter, translated from chinese: "when the icu department was ready to use, it was found that there was a protruding bulge on the catheter.".
Additional Manufacturer Narrative
Initial reporter phone#: unknown.Initial reporter e-mail: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary since no photos or samples displaying the reported condition of catheter defective / damaged were available for examination, we were unable to fully investigate this incident.Dhr was reviewed and no qns or other events were found related to the complaint stated by the customer.According to sampling plan applied for product performance, this lot was accepted.
Event or Problem Description
It was reported a protruding bulge was found on the bd saf-t-intima¿ safety system with removable prn before use.The following information was provided by the initial reporter, translated from chinese: "when the icu department was ready to use, it was found that there was a protruding bulge on the catheter".

• Brand Name: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15667302
• Report Number: 9610847-2022-00405
• Device Sequence Number: 12557387
• Product Code: FOZ
• UDI-Device Identifier: 00382903833351
• UDI-Public: (01)00382903833351
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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 Expiration Date: 05/31/2025
• Device Catalogue Number: 383335
• Device Lot Number: 1140455
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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