MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Model Number 383323

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

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 silicone oil was found in 15 bd saf-t-intima¿ iv catheter safety systems.The following information was provided by the initial reporter, translated from (b)(6): "during hospital operating room using the sti needle, they gave feedback that there was a foreign body at the catheter tube outer wall and the tip, after the nurse punctured success but cannot deliver tube smoothly, so they pulled out the needle for inspection, found that the outer wall of the catheter tube and pinpoint unknown yellow material, the rep timely follow-up and unidentified material is silicone oil, customers are skeptical whether for silicone oil can enter human body, in addition, this problem also happened in (b)(6) 2021, and now it appears again.".

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue was not confirmed upon inspection of the photo because the physical sample is needed to confirm the 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.H3 other text : see h.10.

Event Description

It was reported that silicone oil was found in 15 bd saf-t-intima¿ iv catheter safety systems.The following information was provided by the initial reporter, translated from chinese: "during hospital operating room using the sti needle, they gave feedback that there was a foreign body at the catheter tube outer wall and the tip, after the nurse punctured success but cannot deliver tube smoothly, so they pulled out the needle for inspection, found that the outer wall of the catheter tube and pinpoint unknown yellow material, the rep timely follow-up and unidentified material is silicone oil, customers are skeptical whether for silicone oil can enter human body, in addition, this problem also happened in (b)(6) 2021, and now it appears again.".

• 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: 13159831
• MDR Text Key: 289854622
• Report Number: 9610847-2021-00632
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833239
• UDI-Public: 30382903833239
• 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: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383323
• Device Catalogue Number: 383323
• Device Lot Number: 1021372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2021
• 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