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

Catalog Number 383336

Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this occurrence.After analyzing the provided information by customer, this reported defect could be related with an use incorrect from device, besides without sample or photo defective for evaluation, we cannot confirm or associate the defects to manufacturing process.In our process the material is released before to be of packaged and, during this activation have not reported safety mechanism failure and exposed cannula.Instruction sheet (b)(4), show correct way to perform the activation, this instruction no indicate that during the retracting the needle, pvc tubing cannot be enclosed with the clamp slide.P-eura (b)(4) show the procedures used to assemble this product.Root cause description: based on investigation results to date root cause cannot be determined.Rationale: no capa was opened since this issue could not be confirmed as manufacturing related.The initial reporter also notified the fda on 30, march 2018.Medwatch report # mw5076242.

Event Description

It was reported by the nurse that the bd saf-t-intima¿ iv catheter safety system device caused a needlestick because of tubing malfunction.When the nurse was retracting the needle, through the enclosed tubing, the needle pierced the tubing and stuck the nurse¿s finger.Reported after use.Medical intervention required.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Type of Device: INTRAVENOUS 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: 7491734
• MDR Text Key: 107560445
• Report Number: 9610847-2018-00134
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903833368
• UDI-Public: 00382903833368
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 383336
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention