MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ WITH Y ADAPTER YEL 24GA X 19MM; INTRAVASCUALR CATHETER

Catalog Number 383319

Device Problems Leak/Splash (1354); Material Separation (1562)

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

Event Date 11/04/2022

Event Type  malfunction  

Event Description

It was reported while using bd saf-t-intima with y adapter yel 24ga x 19mm the tubing separated and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: ¿the stopper piece of the subcut line that the needle pulls out of is falling off the subcut lines.It is supposed to be tightly luer-locked on, but they are falling off, causing meds to leak and patients are missing meds as a result.

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.H6: investigation summary : our quality engineer inspected the 1 sample and 1 photo submitted for evaluation.The reported issue of separation adapter from tubing was not confirmed upon inspection and testing of the sample.Analysis of the sample showed that the returned sample had no abnormalities or defects.The sample underwent manual pull force testing and was found to be compliant.Bd determined that the cause of the failure cannot be associated to the manufacturing process since the defect was not confirmed.Dhr was reviewed and no qns or other events were found related to the complaint stated by the customer.According to sampling plan applied for product performance, this lot was accepted.

Event Description

It was reported while using bd saf-t-intima¿ with y adapter yel 24ga x 19mm the tubing separated and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: ¿the stopper piece of the subcut line that the needle pulls out of is falling off the subcut lines.It is supposed to be tightly luer-locked on, but they are falling off, causing meds to leak and patients are missing meds as a result.

• Brand Name: BD SAF-T-INTIMA¿ WITH Y ADAPTER YEL 24GA X 19MM
• Type of Device: INTRAVASCUALR 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: 15889885
• MDR Text Key: 307692111
• Report Number: 9610847-2022-00445
• 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: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383319
• Device Lot Number: 1181313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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