MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 20 G X 1 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383336

Device Problems Break (1069); Detachment Of Device Component (1104); Shielding Failure (1568)

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

Event Date 06/17/2016

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.(b)(4).

Event Description

There were two specific issues reported associated with a 20 g x 1 in.Bd saf-t-intima iv catheter safety system.The guide wire broke off during removal after successful iv insertion (occurred in 22 and 20 gauge iv catheters).Staff report that when removing the trocar, it doesn't sheath into the protective sleeve, leaving sharps exposed.Specific details regarding the number of incidents of each issue and which iv catheter was used in each incident were not provided and the initial reporter only provided catalog and lot information for the 20 gauge device.No injury or medical intervention was reported.

Manufacturer Narrative

Results: a sample was not returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6060507.A manufacturing review revealed that no equipment, instrument, process, or surfaces could cause the type of damage reported.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Manufacturer Narrative

On (b)(6) 2017, an email from bd personnel was received reporting the product complaint (originally reported on the initial mdr on (b)(6) 2016).The email chain shows the original complaint was submitted to the bd privacy department on (b)(6) 2016, however, this information was not sent to the bd regional complaint center until (b)(6) 2017.Therefore the bd notification date has been changed from (b)(6) 2016.Date received by manufacturer: 6/22/2017.

• Brand Name: 20 G X 1 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: 6080715
• MDR Text Key: 59562826
• Report Number: 9610847-2016-00035
• 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,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 383336
• Device Lot Number: 6060507
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2016
• 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