MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN; INTRAVASCULAR CATHETER

Model Number 383313

Device Problem Material Puncture/Hole (1504)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/08/2021

Event Type  malfunction  

Event Description

It was reported bd saf-t-intima¿ safety system with y adapter 24 ga 0.75 in had damaged tubing, resulting in leakage.The following information was provided by the initial reporter, translated from chinese: "in the international medical department, the extension tube of the indwelling needle was clipped by a small clip during the use of the product, resulting in a large amount of bleeding, and patient complained.".

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

H6: investigation summary our quality engineer inspected the 3 photos submitted for evaluation.The reported issue was not confirmed upon inspection of the photos, a physical sample is needed to confirm the reported defect.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported bd saf-t-intima¿ safety system with y adapter 24 ga 0.75 in had damaged tubing, resulting in leakage.The following information was provided by the initial reporter, translated from chinese: "in the international medical department, the extension tube of the indwelling needle was clipped by a small clip during the use of the product, resulting in a large amount of bleeding, and patient complained.".

• Brand Name: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN
• 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: 13170846
• MDR Text Key: 283487715
• Report Number: 9610847-2021-00637
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833130
• UDI-Public: 30382903833130
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013800
• 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: 01/18/2022

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 Model Number: 383313
• Device Catalogue Number: 383313
• Device Lot Number: 1053923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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