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

Catalog Number	383335
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd saf-t-intima¿ closed iv catheter system the sterility was compromised and the product was broken.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: the child neurology teacher sent the product to the equipment department, and the equipment department reported that before opening the package of the product, it was found that the outer package was burned by high temperature, resulting in cracking of the product.The outer package was deformed, and the plastic packaging inside was melted, which was no longer sterile.
Additional Manufacturer Narrative
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 while using bd saf-t-intima¿ closed iv catheter system the sterility was compromised and the product was broken.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: the child neurology teacher sent the product to the equipment department, and the equipment department reported that before opening the package of the product, it was found that the outer package was burned by high temperature, resulting in cracking of the product.The outer package was deformed, and the plastic packaging inside was melted, which was no longer sterile.
Additional Manufacturer Narrative
H6: investigation summary our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of package defective/damaged was confirmed upon inspection of the photo.However, bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review showed no non-conformances associated with this issue during the production of this batch.See h10.

• Brand Name: BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM
• 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: 14893084
• Report Number: 9610847-2022-00249
• Device Sequence Number: 17696236
• Product Code: FOZ
• UDI-Device Identifier: 00382903833351
• UDI-Public: 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): 07/13/2022

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: 11/30/2023
• Device Catalogue Number: 383335
• Device Lot Number: 9326776
• 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: 06/07/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• 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