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 383313

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

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 before use of the bd saf-t-intima¿ iv catheter safety system ¿when the needle was rotated, the needle separated from the handle.¿ there was no report of injury or medical intervention.

Manufacturer Narrative

Investigation results: after investigation of the returned sample, our quality engineer was able to confirm the reported issue.This damage is manufacturing related and action has been taken to address occurrences of this nature.Dhr for lot number 6208758 was reviewed and we found one qn¿s (b)(4) was generated on august 3, 2016, related to the complaint stated by the customer.Material 383313 with lot number 6208758 was manufactured on july 29, 2016.According to sampling plan applied for product performance, this lot was accepted and released.During this lot number (b)(4) samples were tested by pull test between stylet/puller.This test was performed by qa tech.(b)(4).No values out of specification was found.All relevant information during the dhr review shown that meet all established manufacturing criteria.This defect could be related with method to perform the assembly of z crimping, because after the review this process, we find that there is difference between every operator.Method the assembly of z crimping, no standardized in final assembly.A formal corrective action will not be initiated at this time; because, this complaint is the first in a period of 5 years.We will be monitoring the trend of a specific type of complaint warrants a formal corrective action and resources will be assigned at that time.Other actions taken: quality alert was created to close qn¿s (b)(4), related at reported defect, where a method was standardized to perform z crimping assembly.All personnel that performed this assembly was informed about customer complaint.

• 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
• MDR Report Key: 7334485
• MDR Text Key: 102341145
• Report Number: 9610847-2018-00063
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833130
• UDI-Public: 30382903833130
• Combination Product (y/n): N
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 383313
• Device Lot Number: 6208758
• Date Manufacturer Received: 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other