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 383319

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using bd saf-t-intima¿ iv catheter safety system, there was a safety issue with a demonstration sample.There was no report of patient impact.The following information was reported by the initial reporter, translated from (b)(6) to english: "during a training session with the saf-t-intima catheter, a nurse who handled a saf-t-intima catheter to see how it worked encountered a safety issue with a demonstration sample.The event occurred in front of me.The nurse did not position her fingers at the back pins for the safety catch.Since these were demonstration samples, there was no catheter from this box left at the facility.The other samples remained with the salesperson and myself.".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 05-jan-2022.H6: investigation summary our quality engineer inspected the 1 photo and partial sample submitted for evaluation.The reported issue of safety shield activation failure (catheter) was confirmed to be a molding defective ¿ other failure upon inspection of the samples.Bd determined that the cause of the failure was related to the molding process of the safety shield.There is a possibility that air in the mold got clogged, causing a pour flow of the material, resulting in a defective component.A device history record review showed no non-conformances associated with this issue during the production of this batch h3 other text : see h10.

Event Description

It was reported that while using bd saf-t-intima¿ iv catheter safety system, there was a safety issue with a demonstration sample.There was no report of patient impact.The following information was reported by the initial reporter, translated from french to english: "during a training session with the saf-t-intima catheter, a nurse who handled a saf-t-intima catheter to see how it worked encountered a safety issue with a demonstration sample.The event occurred in front of me.The nurse did not position her fingers at the back pins for the safety catch.Since these were demonstration samples, there was no catheter from this box left at the facility.The other samples remained with the salesperson and myself.".

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13122443
• MDR Text Key: 285065737
• Report Number: 9610847-2021-00625
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 383319
• Device Lot Number: 1082553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 06/06/2022
• Supplement Dates FDA Received: 06/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1