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	383335
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2020
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.
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system experienced difficult safety mechanism/needle disengagement (removal) during use.The following information was provided by the initial reporter: according to the nurse's feedback from the ct room, when the guide wire (needle) was going to pull out after successful puncturing, it was found that the wire could not be completely disengaged.
Event or Problem Description
It was reported that the bd saf-t-intima¿ iv catheter safety system experienced difficult safety mechanism/needle disengagement (removal) during use.The following information was provided by the initial reporter: according to the nurse's feedback from the ct room, when the guide wire(needle) was going to pull out after successful puncturing, it was found that the wire could not be completely disengaged.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 7/30/2020.H.6.Investigation: a device history record review was performed for provided lot number 8115960.The review did not reveal a detected abnormality during the production process that could have contributed to this reported incident.One physical sample and picture samples were received for evaluation by our quality team.Through examination of the samples, the team observed the safety device was not activated completely.This type of defect could result if the instructions for use are not carefully followed.Based on the investigation results, an exact manufacturing defect for this incident could not be identified.H3 other text : see h.10.

• 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: 10348191
• Report Number: 9610847-2020-00226
• Device Sequence Number: 19568704
• 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): 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2022
• Device Model Number: 383335
• Device Catalogue Number: 383335
• Device Lot Number: 8115960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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