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 383312

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

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

Event Date 06/02/2022

Event Type  malfunction  

Event Description

It was reported that foreign matter was found on 5 bd saf-t-intima¿ iv catheter safety systems during use.The following information was provided by the initial reporter, translated from chinese: "when the head nurse of the respiratory department of the hospital performed indwelling needle puncture for the patient on (b)(6) 2022, foreign matter was found at the tip of the catheter tube when the needle core was adjusted after the package of the indwelling needle was opened".

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 foreign matter was found on 5 bd saf-t-intima¿ iv catheter safety systems during use.The following information was provided by the initial reporter, translated from chinese: "when the head nurse of the respiratory department of the hospital performed indwelling needle puncture for the patient on june 2, 2022, foreign matter was found at the tip of the catheter tube when the needle core was adjusted after the package of the indwelling needle was opened".

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the photo.However, 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.

• 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: 14887620
• MDR Text Key: 302341130
• Report Number: 9610847-2022-00247
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833123
• UDI-Public: 30382903833123
• 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: 07/07/2022

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: 383312
• Device Catalogue Number: 383312
• Device Lot Number: 1210971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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