MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD INSYTE-A¿ ARTERIAL CATHETER; INTRAVASCULAR CATHETER

Catalog Number 382802

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

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

Event Date 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

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 insyte-a¿ arterial catheter foreign matter was found before use.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about foreign matter in the package of insyte-a.According to the customer¿s report, fm adhering to the catheter site was found before use.The sales rep.'s comments are as follows: there are cloth-like fibers (white) inside the cap.Please be careful when removing the cap as it is hard to see it with human eyes.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 11-jan-2023.H6.Investigation summary: a device history review was conducted for lot number 2101874.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, two samples were returned to aid in our investigation.During visual analysis, our engineers were able to identify a small black spec on the paper backing of the packaging.Unfortunately, due to the size of the material, our engineers were not able to successfully collect the sample for compositional testing.This event has been confirmed.The most likely root cause for general foreign matter is difficult to identify, as it can originate from packaging personnel or raw materials brought into the manufacturing room.

Event Description

It was reported while using bd insyte-a¿ arterial catheter foreign matter was found before use.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about foreign matter in the package of insyte-a.According to the customer¿s report, fm adhering to the catheter site was found before use.The sales rep's comments are as follows: there are cloth-like fibers (white) inside the cap.Please be careful when removing the cap as it is hard to see it with human eyes.

• Brand Name: BD INSYTE-A¿ ARTERIAL CATHETER
• 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: 16109150
• MDR Text Key: 308648583
• Report Number: 9610847-2022-00511
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 382802
• Device Lot Number: 2101874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2022
• 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