MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN; INTRAVASCULAR CATHETER

Catalog Number 383323

Device Problem Material Perforation (2205)

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

Event Date 07/14/2023

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 1210978; d4.Medical device expiration date: 31jul2025; h4.Device manufacture date: 11aug2021.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd saf-t-intima¿ safety system with y adapter 22 ga 0.75 in the needle pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter: all for saf-t-intima: no flash is being seen when line is inserted, needle is not visible above sheath, the needle is puncturing the side of the catheter sheath when withdrawing the needle.

Manufacturer Narrative

Investigation summary: it was reported the needle is puncturing the side of the catheter sheath when withdrawing the needle.As a sample was not returned, a thorough sample investigation could not be completed.A device history record review was completed for provided material number 383323, lot 1210978.The review did not reveal any quality notifications related to complaint reported.According to sampling plan applied for product performance, this lot was accepted.Based on the investigation, bd was not able to confirm the indicated failure mode as no defective samples or photos were returned.

Event Description

It was reported while using bd saf-t-intima¿ safety system with y adapter 22 ga 0.75 in the needle pierced the catheter.There was no report of patient impact.The following information was provided by the initial reporter: all for saf-t-intima: no flash is being seen when line is inserted, needle is not visible above sheath, the needle is puncturing the side of the catheter sheath when withdrawing the needle.

• Brand Name: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17446253
• MDR Text Key: 320709341
• Report Number: 9610847-2023-00209
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833239
• UDI-Public: (01)30382903833239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

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: Other
• Device Catalogue Number: 383323
• Device Lot Number: 2014866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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