MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA WITH MAXZERO; PERIPHERAL IV CATHETERS

Catalog Number 383552

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that bd nexiva with maxzero the extension set disconnected from the catheter.The following information was provided by the initial reporter: the extension set came disconnected from the catheter.08 nov the patient was moved from a higher level of care to my med surg floor.She had a 20g catheter in her arm.The catheter tubing came apart from the hub of the catheter.The patient did not suffer an adverse effect from this nor was there a delay of care.The iv was removed and restarted with another catheter.My staff did not keep the defective catheter.However, the have been informed for any future incident they are to put the iv catheter and package in a biohazard bag and return to me.I will then contact bd.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.

Manufacturer Narrative

As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.

Event Description

No additional information received.

• Brand Name: BD NEXIVA WITH MAXZERO
• Type of Device: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18236406
• MDR Text Key: 330118806
• Report Number: 9610847-2023-00344
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835523
• UDI-Public: (01)30382903835523
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383552
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1