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 383329

Device Problem Material Separation (1562)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

It was reported that the bd saf-t-intima¿ iv catheter safety system prn separated from the adapter while the device was being inserted into the patient.The following information was provided by the initial reporter: "rubber port that remains after needle is removed as been twisting off while inserted in the patient.Rubber port that remains after needle is removed became loose and fell off while device inserted in patient".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6: investigation summary: a device history record review was completed for provided material number 383329 and lot number 9327785.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.The product is manually made and a 100% inspection is performed by the operators to ensure that the product meets acceptance criteria.Controls have been implemented in the manufacturing area which have been effective in controlling this type of characteristic.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.

Event Description

It was reported that the bd saf-t-intima¿ iv catheter safety system prn separated from the adapter while the device was being inserted into the patient.The following information was provided by the initial reporter: "rubber port that remains after needle is removed as been twisting off while inserted in the patient.Rubber port that remains after needle is removed became loose and fell off while device inserted in patient.".

• 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: 14163985
• MDR Text Key: 289786378
• Report Number: 9610847-2022-00149
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 383329
• Device Lot Number: 9327785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2019
• 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