MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM 20GX0.1; INTERVASCULAR CATHETER

Catalog Number 383335

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation: two representative samples were received for evaluation.Visually the samples not present any damage, only the tray has damages.Both samples will be tested functionally by device activation.Dhr for lot number 6302611 was reviewed and no qns or other events were related to the complaint stated by the customer.Material (b)(4) with lot number 6302611 was manufactured on november 25, 2016.According to sampling plan applied for product performance, this lot was accepted and released.During this lot number 140 samples were activated by qa tech to perform 3 test of pull force.Stylet/cannula removal force through inserter wings.Stylet/cannula removal force through the prn component.Outer safety sheath disconnection force from prn component.No values out of specification or problems during activation were found.All relevant information during the dhr review shown that meet all established manufacturing criteria.No internal rejection was generated during the manufactured of this lot number.We could not determine a root cause for this issue, it is possible that the failure occurred during incorrect use of the device.Dhr did not showed evidence of an issue related to the reported by customer.Bd was not able to duplicate or confirm the customer¿s indicated failure mode investigation comments: after evaluate two representative samples we were not able to associate the reported defect to the mfg.Process.This reported defect could be related with an incorrect use of the device by user and a possible cause to leave exposed cannula, it is that during the device activation is made since adapter sti prn, removing safety mechanism.Instruction sheet (b)(4), show correct way to perform this activation.Representative samples were functionally tested and meets specification criteria requested during manufacturing.Based on investigation results to date, root cause for manufacturing process cannot be determined.(b)(4).

Event Description

It was reported that the safety on a bd saf-t-intima¿ integrated safety catheter system 20gx0.1, with removable prn adapter did not cover the needle during use.No injury or medical intervention.

• Brand Name: BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM 20GX0.1
• Type of Device: INTERVASCULAR 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: 6920016
• MDR Text Key: 89813777
• Report Number: 9610847-2017-00097
• 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: Other
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 383335
• Device Lot Number: 6302611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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
• Patient Outcome(s): Other