MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 22 G X 1 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383662

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Device manufacture date: unknown.Medical device expiration date: n/a.(b)(6).Results: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A device history review was not conducted because a lot number could not be determined.Conclusion: bd was unable to confirm the customer¿s indicated failure mode because no samples or photos were received to confirm the stated defect.(b)(4).

Event Description

It was reported that the nurse received a dirty needle stick after use of a 22 g x 1 in.Bd nexiva¿ closed iv catheter system on a patient.Nurse believes this was due to a failed safety shield of the needle.She received medical intervention, including post exposure lab work and vaccination.

• Brand Name: 22 G X 1 IN. BD NEXIVA¿ CLOSED IV CATHETER 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: 6956155
• MDR Text Key: 89581785
• Report Number: 9610847-2017-00116
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 383662
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2017
• 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