MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 22G X 0.75 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383323

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation: it is unknown if a sample is available for evaluation.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that the safety sheath did not activate.No injury reported.

Manufacturer Narrative

Device evaluation: result - one used unit was received with the original package opened.Visually, we can observe an exposed cannula within the packaging.This safety device was not activated during use.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 6208763.This device was manufactured on august 2, 2016.According to sampling plan applied for product performance, this lot was accepted and released.The product is tested by pull force and through of the different manufacturing process and no equipment, instrument, process and/or surfaces that could cause this kind of damage were detected.Conclusion - bd was not able to confirm the customer¿s indicated failure mode.After evaluation of the used unit and being able to perform the activation without any problems, this could not be confirmed as a manufacturing related issue.An absolute root cause for this incident cannot be determined.

• Brand Name: 22G X 0.75 IN. 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: 6190078
• MDR Text Key: 63227348
• Report Number: 9610847-2016-00060
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 383323
• Device Lot Number: 6208763
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other