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

Catalog Number	383346
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during insertion the device was unable to penetrate the vein due to a deformity on the catheter with a bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter, translated from (b)(6) to english: on (b)(6) 2019, during penetration, it's noticed that 18g sti unable to penetrate into the vein nurse retracted partial of the catheter and noticed that the catheter's edge valgus.
Event or Problem Description
It was reported that during insertion the device was unable to penetrate the vein due to a deformity on the catheter with a bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2019, during penetration, it's noticed that 18g sti unable to penetrate into the vein nurse retracted partial of the catheter and noticed that the catheter's edge valgus.
Additional Manufacturer Narrative
Investigation summary: a device history review was conducted for lot number 7271749.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, the sample submitted to our facility was subjected to ping and drag testing to determine conformity to product specifications.Based on the established limits, our engineers found the submitted device to be within product specifications and functionally normal.Based on these findings, the root cause for this complaint could not be determined at the conclusion of our review.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY 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
• MDR Report Key: 9292977
• Report Number: 9610847-2019-00670
• Device Sequence Number: 2245565
• Product Code: FOZ
• UDI-Device Identifier: 30382903833468
• UDI-Public: 30382903833468
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 383346
• Device Lot Number: 7271749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other