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

Catalog Number 383323

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

Date received by manufacturing: changed/corrected from 11/27/2107 to 11/27/2017.

Manufacturer Narrative

The customer returned 411 representative units for evaluation. Our quality engineer visually inspected the returned units and was unable to identify any damage to any of the components. Pull testing was then performed and each unit met manufacturing standards. Puller/stylet (pull test) average: 10. 48 pounds; minimum: 6. 60 pounds; maximum: 13. 49 pounds. Specification: 2. 7 pounds (minimum). Having found no values out of specification, we were not able to associate the reported defect to the manufacturing process. A dhr for lot number 7144554 was reviewed and no qns or other events were related to the complaint stated by the customer. A manufacturing review revealed that no equipment, instrument, process and/or surfaces that could cause this kind of damage were detected. Conclusion: with the information provided by the customer and the results obtained in the evaluation of representative samples, we cannot determine the root cause. No capa was opened since this issue could not be confirmed as manufacturing related.

Manufacturer Narrative

Date of event: unknown. 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 during use of the bd saf-t-intima¿ iv catheter safety system the assembly that pulls the stylet broke apart, the heplock type port popped right off on a few recent starts. There was no report of injury or medical intervention.

• 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
• 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: 7129219
• MDR Text Key: 256088085
• Report Number: 9610847-2017-00192
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 383323
• Device Lot Number: 7144554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2017
• 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: 12/19/2017 Patient Sequence Number: 1