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

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/02/2021

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)(4) has been listed in sections manufacturer name, city and state and mfr site.And the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that unspecified bd¿ connecta was damaged and leaked.The following information was provided by the initial reporter: from (b)(6) 2021, the nurse opened multiple infusion channels for the patient to conduct infusion, nutrition, treatment, etc.At the same time.During the medical three-pass, it was found that one end was deformed and tightly closed, and the three-way connection was leaking.Replace the medical three-way.The operation caused liquid contamination without causing harm to the patient.After communication with the customer, the product was treated as waste after the incident, and the product batch number and other information were unknown.After communication with the customer, if the product quality is suspected to have problems, please keep relevant products or relevant videos or pictures, so as to further find the reason, and the customer accepts and approves.

• Brand Name: UNSPECIFIED BD¿ CONNECTA
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12580768
• MDR Text Key: 274940469
• Report Number: 2243072-2021-02450
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• 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
• Date Manufacturer Received: 09/07/2021
• 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