MAUDE Adverse Event Report: UNSPECIFIED BD ALARIS¿ INFUSION SET; 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 12/03/2019

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 and (b)(6) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd alaris¿ infusion set drip chamber broke when pressing it to start the equipment infusion.The following information was provided by the initial reporter, translated from spanish to english: inserting the bayonet into the solution and when pressing the drip chamber to start the equipment infusion, the drip chamber fractured.There were no consequences.

Manufacturer Narrative

Investigation summary: a sample was not available for investigation, however information provided from the customer indicates that the drip chamber cracked during priming.The material and lot number of the affected product were not provided to assist the investigation.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular feedback.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.In this instance, without the complaint sample or additional information about the affected model code it is not possible to conclusively link this feedback to previous reports.H3 other text : see h10.

Event Description

It was reported that the unspecified bd alaris¿ infusion set drip chamber broke when pressing it to start the equipment infusion.The following information was provided by the initial reporter, translated from spanish to english: inserting the bayonet into the solution and when pressing the drip chamber to start the equipment infusion, the drip chamber fractured.There were no consequences.

• Brand Name: UNSPECIFIED BD ALARIS¿ INFUSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12546807
• MDR Text Key: 273783335
• Report Number: 2243072-2021-02405
• 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,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• 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: 09/30/2021
• 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