MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ALARIS¿ INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Material Puncture/Hole (1504)

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

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(6) has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd alaris¿ infusion set tubing had a hole in it near the pump.The following information was provided by the initial reporter: " 1.Can you provide complete details of the complaint ? need a clear clarification with the complaint.Alaris pump alarmed for "check iv tubing".Iv tubing found to have a hole in the portion of tubing that goes in the alaris pump.2.Can you provide material and batch number? not available 3.What is the date of event, (b)(6) 2023.4.Did the event directly, or indirectly involve a patient or user? yes, patient involvement.5.Did the event involve an urgent/life threatening medical situation? no.6.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Please include treatment/intervention provided and the outcome.Medication was stopped briefly new medication was hung with new tubing.7.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.No negative impact to the patient was noted".

• Brand Name: UNSPECIFIED BD ALARIS¿ INFUSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17935025
• MDR Text Key: 325677139
• Report Number: 2243072-2023-01858
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2023

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: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1