MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 18 G X 1.00 IN.; INTERVASCULAR CATHETER

Catalog Number	383346
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
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 has been reported that one bd saf-t-intima iv catheter safety system 18 g x 1.00 in.Has been found with the cannula breaking off during use.The following has been provided by the initial reporter: it's noticed that needle broken during needle retraction.18ga sti was removed once the needle broken was noticed , no further injury caused on patient; the end user confirmed that no improper operation exist.
Additional Manufacturer Narrative
Investigation: a device history review was conducted for lot number 7349723.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.One used unit and one photo were received for evaluation.Bd was able to duplicate and confirm by the customer indicated failure mode.Needle no showed damage or broken.However the team noticed a separation between needle/stylet was observed.This defect could be reproduced of 2 ways.1.An incorrect placement of the stylet in the needle.Work instruction si-12-wi-001sp mentions the steps to perform this assembly however if the step # 3 was not carried out correctly, stylet never is crimping.2.Misalignment of the lower die in crimping station needle broken based on the investigation conclusion, needle broken is not confirmed.Needle no showed damage or broken.Separation needle/stylet.Based on the investigation conclusion the condition found is confirmed.Incorrect placement of the stylet tip in the needle caused the separation between needle/stylet assembly or a misalignment of the lower die in a crimping station.
Event or Problem Description
It has been reported that one bd saf-t-intima iv catheter safety system 18 g x 1.00 in.Has been found with the cannula breaking off during use.The following has been provided by the initial reporter: it's noticed that needle broken during needle retraction 18ga sti was removed once the needle broken was noticed , no further injury caused on patient; the end user confirmed that no improper operation exist.

• Brand Name: BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 18 G X 1.00 IN.
• Common Device Name: INTERVASCULAR 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: 9280066
• Report Number: 9610847-2019-00663
• Device Sequence Number: 19667430
• Product Code: FOZ
• UDI-Device Identifier: 00382903833467
• UDI-Public: 00382903833467
• 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): 12/20/2019

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: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 383346
• Device Lot Number: 7349723
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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