MAUDE Adverse Event Report: BECTON DICKINSON BD UNDISCLOSED PIVC; PERIPHERAL IV CATHETERS

Catalog Number UNKNOWN

Device Problem Break (1069)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.In this mdr, bd franklin lakes, nj has been listed in sections d.3.And g.1.As the manufacturing site is unknown.

Event Description

It was reported that bd undisclosed pivc catheter broke from the hub.The following information was provided by the initial reporter: i wanted to follow up from what i found and where we are in the process of the product concern.I spoke to melissa regarding the iv site below.Unfortunately as i stated yesterday the staff did not keep the product , but with the picture and speaking to the resource nurse who was involved with this patient, melissa and the iv team , they came to the same conclusion that the vascular x-ray had shown that there was no catheter left inside the patient vessel.I have circled the area and you can view the catheter was attached to the old dressing.The resource nurse stated ¿the iv was lying on top of the skin and not in the vessel upon removal.¿ melissa and i spoke and she stated¿ it was very evident that this iv was lacking care and maintenance.¿ melissa stated¿ this patient was in house for several days and the same iv was in during her stay.¿ the iv was a saline lock and no iv fluids were running through it.

Event Description

- can you please provide the material and lot number associated with reported issue? - can you please provide an exact date of event? - any adverse event or serious injury reported to patient? if yes, please provide the details.- how was the issue resolved? customer response on (b)(6) 2024.The rep teresa came in and spoke to the er team.The product has already been sent in for review.3/1/2024 was the event date.No harm to the patient.Another product was pulled and used on the patient.

Manufacturer Narrative

Our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of catheter broke / separated after placement was confirmed upon inspection of the photo.However, bd cannot confirm the cause of the failure since no sample was returned for evaluation.With out a batch number we were unable to review production records for any failures that may have occurred during manufacturing.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.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 UNDISCLOSED PIVC
• Type of Device: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19091454
• MDR Text Key: 340566617
• Report Number: 2243072-2024-00540
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1