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

Catalog Number 383590

Device Problem Separation Problem (4043)

Patient Problem Menstrual Irregularities (1959)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that bd.The following information was provided by the initial reporter: during injection the end popped off.Additional information: during contrast injection at 2.0ml/sec the tip pooped off, which caused, 1) a mess, 2) delay in scan, 3) delay in patient care, 4) requiring a new iv line to be placed.It was unclamped and injection rate was 2ml/sec.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

Customer response: how was treatment completed for customer? started a new iv date of event: february 1, 2024 please confirm whether there was any patient impact.Yes, patient was a difficult stick, we had to start another line which caused delay in patient care.Did the event interrupt the administration of any medication, or cause a clinically significant delay in medication, that negatively impacted the patient? if yes, please provide details.During contrast injection at 2.0ml/sec the tip pooped off, which caused, 1) a mess, 2) delay in scan, 3) delay in patient care, 4) requiring a new iv line to be placed any physical sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? the item has been dispose of upon patient discharge.Can you please provide more details and describe how the product is damaged.During contrast injection at 2.0ml/sec the tip pooped off.

Manufacturer Narrative

Our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of leakage was confirmed upon inspection of the sample photo.Analysis of the sample photo showed that the tubing of the device disconnected from the luer body.Further examination of the photo showed that there was adhesive on the connection point of the catheter and luer body.Bd determined that the cause of the failure was related to our manufacturing process.It is most likely that the adhesive did not cure correctly during production and the product was likely not properly pull tested prior to release.A quality alert was generated to inform manufacturing personnel of the failure observed to increase their awareness of the potential causes of separation failures.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.

• Brand Name: BD NEXIVA DIFFUSICS
• 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: 18778827
• MDR Text Key: 336868268
• Report Number: 9610847-2024-00040
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835905
• UDI-Public: (01)30382903835905
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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: 383590
• Device Lot Number: 3214185
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1