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

Model Number	383346
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system tubing had a hole in it during use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "tubing attached to y adapter had a hole in it, requiring the iv to be replaced ".
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot number 9326780.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.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system tubing had a hole in it during use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "tubing attached to y adapter had a hole in it, requiring the iv to be replaced ".

• 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: 10551220
• Report Number: 9610847-2020-00286
• Device Sequence Number: 14236609
• Product Code: FOZ
• UDI-Device Identifier: 30382903833468
• UDI-Public: 30382903833468
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

1 Device was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 383346
• Device Catalogue Number: 383346
• Device Lot Number: 9326780
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No