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

Catalog Number	383335
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: a sample was not returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6146716.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
Event or Problem Description
It was reported that a nurse recalled on 3 occasions where leaking occurred on bd saf-t-intima¿ integrated safety catheter system e-tubing adapters when connected with high pressure infusion devices.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: one used unit was received for evaluation.Leak testing was performed on the returned unit and no leakage was observed.A root cause for this incident could not be identified based on the provided sample.Investigation conclusion: based on evaluating the reported defect was not confirmed.No leakage was found.Without leakage in the sample received; we were not able to associate the reported defect to the mfg.Process.Root cause description: the user used other brand infusion device for high pressure with our device causing leakage.Our product is not designed to be used with power injector.

• Brand Name: BD SAF-T-INTIMA¿ INTEGRATED SAFETY 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
• MDR Report Key: 7154807
• Report Number: 9610847-2017-00210
• Device Sequence Number: 140404
• 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,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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: Nurse
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 383335
• Device Lot Number: 6146716
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 02/22/2018
• 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