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

Catalog Number 383313

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: the reported defect was not confirmed in the image received.(b)(4) units were used to reproduce the reported defect; however, the only way was activating the slide clamp in the pvc tubing right below the wing, as we activate the puller holding the adapter the tube gets tangle.We cannot confirm or associate the reported defect to manufacturing process since, it is not related with our assembly process.Always refer to ifu (b)(4) for product usage recommendations.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.No corrective action required at the failure.Process fmea (b)(4) was reviewed and there are proper controls in place to detect product malfunctions.We could not found the exactly root cause of the issue; however, a possible cause could be an incorrect use of the product.No capa was opened since this issue could not be confirmed as manufacturing related.

Event Description

It was reported that the safety mechanism on a bd saf-t-intima¿ iv catheter safety system failed to function properly.There was no report of exposure, injury or medical interventions.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• 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: 7565956
• MDR Text Key: 110181765
• Report Number: 9610847-2018-00150
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833130
• UDI-Public: 30382903833130
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 383313
• Device Lot Number: 7143717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2017
• 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