MAUDE Adverse Event Report: MALLINCKRODT DAR SRL DAR; CONNECTOR, AIRWAY (EXTENSION)

Model Number 610/5257

Device Problem Connection Problem (2900)

Patient Problem Hyperventilation (1910)

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the rubber cap of the double swivel connector was not opened, the gas would stay with the patient, however at that time the accident occurred due to the rubber cap had not been opened.The patient was in hyperventilation temporarily.They used the product in unintended use and that was a mistake of the hospital side.

• Brand Name: DAR
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• Manufacturer (Section G): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8502079
• MDR Text Key: 141574562
• Report Number: 2936999-2019-00267
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K942392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 610/5257
• Device Catalogue Number: 610/5257
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2019
• 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