MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.75 IN; INTRAVASCULAR CATHETER

Model Number 383538

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that an unspecified number of bd nexiva¿ closed iv catheter systems - dual port 20 ga 1.75 in were involved in a serious injury in the form of a change in the course of treatment during use.Due to painful application, multiple patients have requested to have the placement of their iv stopped.It has not been specified whether alternative medical treatment/intervention was sought or received as a result.The following information was provided by the initial reporter: material no.: 383538, batch no.: 9325212.Per email: so i just messed with the 20g.It feels like there's a little lip on the tip of the needle.If you run something over the tip you can feel it catch.It's not like that on the 22's.Nexiva needles 20g 1.75" have been really dull lately.Last few boxes we've had.The lot number 9325212.Help!!!! this isn't ok for our vets! very painful for the patient.Multiple have requested stopping the placement of iv.

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one 20ga nexiva closed iv catheter system ¿dual port unit within an undamaged opened package from lot number 9325212, reference number 383538.All components are present and intact.Through the visual microscopic evaluation damage was observed on the needle tip.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect.Corrective actions, capa#708490, have been initiated to investigate this type of incident and identity the root cause.The dhr for lot number 9325212 has been reviewed.Qn (b)(4) (suspect penetration and drag oos) was initiated and could potentially be related to this incident.

Event Description

It was reported that an unspecified number of bd nexiva¿ closed iv catheter systems - dual port 20 ga 1.75 in were involved in a serious injury in the form of a change in the course of treatment during use.Due to painful application, multiple patients have requested to have the placement of their iv stopped.It has not been specified whether alternative medical treatment/intervention was sought or received as a result.The following information was provided by the initial reporter: material no.: 383538.Batch no.: 9325212.Per email: so i just messed with the 20g.It feels like there's a little lip on the tip of the needle.If you run something over the tip you can feel it catch.It's not like that on the 22's.Nexiva needles 20g 1.75" have been really dull lately.Last few boxes we've had.The lot number 9325212.Help!!!! this isn't ok for our vets! very painful for the patient.Multiple have requested stopping the placement of iv.

Event Description

It was reported that an unspecified number of bd nexiva¿ closed iv catheter systems - dual port 20 ga 1.75 in were involved in a serious injury in the form of a change in the course of treatment during use.Due to painful application, multiple patients have requested to have the placement of their iv stopped.It has not been specified whether alternative medical treatment/intervention was sought or received as a result.The following information was provided by the initial reporter: material no.: 383538 batch no.: 9325212 per email: so i just messed with the 20g.It feels like there's a little lip on the tip of the needle.If you run something over the tip you can feel it catch.It's not like that on the 22's.Nexiva needles 20g 1.75" have been really dull lately.Last few boxes we've had.The lot number 9325212.Help!!!! this isn't ok for our vets! very painful for the patient.Multiple have requested stopping the placement of iv.

Manufacturer Narrative

The following information has been updated: b.3.Date of event: (b)(6) 2020.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.75 IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9923844
• MDR Text Key: 188327438
• Report Number: 1710034-2020-00241
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835387
• UDI-Public: 30382903835387
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 383538
• Device Catalogue Number: 383538
• Device Lot Number: 9325212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 03/11/2020; 03/11/2020
• Supplement Dates FDA Received: 04/21/2020; 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other