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

Catalog Number UNKNOWN

Device Problem Packaging Problem (3007)

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

Event Date 01/02/2024

Event Type  malfunction  

Event Description

It was reported that bd undisclosed pivc device had an exposed inner needle body and the package was damaged.The following information was provided by the initial reporter, translated from chinese to english: when a nurse was using a closed puncture-proof intravenous indwelling needle to replenish intravenous infusion for a 40-bed patient, she found that the packaging was damaged and the inner needle body was exposed.She immediately put on a well-packaged closed anti-puncture intravenous catheter, added fluids to the patient, and reassured the patient.Patients and their families understand and cooperate.

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.

Manufacturer Narrative

A complaint history review cannot be performed as no material and batch/lot number was provided.A device history record(dhr) review could not be performed as no material and batch/lot number was made available for this reported event.A retain sample analysis review could not be performed as no material and batch/lot number was made available for this reported event.A review of the applicable p-eura indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.Root cause couldn't be determined due to unavailability of sample, material and batch/lot number information.

Event Description

Previously provided lot# could not be associated with any valid lot numbers in our system.Record updated to display the lot as unknown.

• Brand Name: BD UNDISCLOSED PIVC DEVICE
• 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: 18713089
• MDR Text Key: 336317061
• Report Number: 2243072-2024-00177
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/28/2024
• 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