MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 20 G X 1.00 IN.; INTRAVASCULAR CATHETER

Catalog Number	383335
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/11/2019
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.
Event or Problem Description
It was reported that during use of the bd saf-t-intima iv catheter safety system with prn adapter 20 g x 1.00 in.The extension tubing detached from the needle wing hub when needle retraction during the penetration process.This resulted in blood excess from the needle wing hub.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: it's noticed that ext.Tubing detached from the needle wing hub when needle retraction during the penetration process which result in blood excess from the needle wing hub.Detailed leakage blood waiting for further confirmation.No blood or bodily fluids exposed to the nurse.
Additional Manufacturer Narrative
Investigation summary: a device history review was conducted for lot number 8057587.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 provided sample was subjected to leakage testing; closer inspection of the location of the observed leak revealed that the device lacked cyclohexanone.Cyclohexanone acts as a seal between the extension tubing and the wing/inserter, and was neglected by manufacturing personnel during the manual assembly of the components.To address this issue our facility has issued a retraining to the appropriate personnel.
Event or Problem Description
It was reported that during use of the bd saf-t-intima iv catheter safety system with prn adapter 20 g x 1.00 in.The extension tubing detached from the needle wing hub when needle retraction during the penetration process.This resulted in blood excess from the needle wing hub.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: it's noticed that ext.Tubing detached from the needle wing hub when needle retraction during the penetration process which result in blood excess from the needle wing hub.Detailed leakage blood waiting for further confirmation.No blood or bodily fluids exposed to the nurse.

• Brand Name: BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER 20 G X 1.00 IN.
• 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: 8847074
• Report Number: 9610847-2019-00491
• Device Sequence Number: 2730687
• Product Code: FOZ
• UDI-Device Identifier: 30382903833352
• UDI-Public: 30382903833352
• 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): 09/12/2019

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: 02/28/2022
• Device Catalogue Number: 383335
• Device Lot Number: 8057587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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