MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

Catalog Number 383592

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

Bd received actual samples and representative samples from the customer facility for investigation. The actual sample received was inspected under microscope with 183x magnification, this help us to visualize correctly the broken area. Once the sample was inspected, it was observed that the damage had a triangle way in the part of the catheter broke near to the skin. Representative samples were taken in order to reproduce the failure mode mentioned per the customer. It was confirmed as a user related issue and not related to manufacturing process. It¿s important to mentioned that during the device placement the nurse did not follow up the right procedure. A review of the device history record revealed no irregularities during the manufacture of the reported lot number. Conclusion: bd was able to duplicate or confirm the customer¿s indicated failure mode. During the sample evaluation it was confirmed that this defect can be caused during an incorrect technique of device placement, if the catheter is damaged or broken per the cannula we can observe the same failure mode in our manufacturing samples.

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 the catheter from a bd nexiva¿ diffusics¿ closed iv catheter system partially broke off in patients arm. Medical intervention required.

• Brand Name: BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7097262
• MDR Text Key: 109975985
• Report Number: 9610847-2017-00171
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 383592
• Device Lot Number: 7241693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/07/2017 Patient Sequence Number: 1