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
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2018
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 the safety mechanism on the bd saf-t-intima¿ iv catheter safety system wouldn¿t activate during use.There was no report of exposure, injury, or medical intervention noted.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: female.Event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.
Event or Problem Description
It was reported that the safety mechanism on the bd saf-t-intima¿ iv catheter safety system wouldn¿t activate during use.There was no report of exposure, injury, or medical intervention noted.
Event or Problem Description
It was reported that the safety mechanism on the bd saf-t-intima¿ iv catheter safety system wouldn¿t activate during use.There was no report of exposure, injury, or medical intervention noted.
Additional Manufacturer Narrative
H.6.Investigation summary: the reported safety shield activation failure by customer was not confirmed after the sample was evaluated.Sample evaluation was performed; however, manufacturing process where the material is built was inspected and no equipment and instrument process that could cause this kind of damage were detected.Although the sample was received with the stylet bent, this sample could be activated without problems following the ifu d12556.Always refer to ifu for product usage recommendations.No corrective action required at the failure.Process fmea rm4797 was reviewed and there are proper controls in place to detect product malfunctions.Investigation conclusion: based on investigation results to date, the root cause is related with lack of training in the use of the product.

• 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
• MDR Report Key: 7704433
• Report Number: 9610847-2018-00214
• Device Sequence Number: 2771019
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2018

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: No Information
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 383346
• Device Lot Number: 6004940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018; 06/28/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/09/2018; 09/12/2018
• 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