MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC DISPOSABLE CIRCUITS; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE

Catalog Number 100/905/340-CH

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Insufficient Information (4580)

Event Date 09/18/2023

Event Type  Injury  

Event Description

It was reported that "single limb ventilator circuit connected to a ventilator requiring use of a two limbed ventilator tubing circuit.Packaging lacked warning and ventilator able to deliver inspiration but did not allow for exhalation.The ventilator model used was the zoll eagle ii which requires the 2-limb circuitry tubing; however, the therapist utilized the single limb circuit tubing intended for use with the parapac transport ventilator.There was temporary harm ¿ the insertion of a chest tube".

Manufacturer Narrative

D4: expiration date and h4: manufacture date is unknown; no information is available based on reported lot number.H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: PNEUPAC DISPOSABLE CIRCUITS
• Type of Device: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18421018
• MDR Text Key: 331634163
• Report Number: 3012307300-2023-12280
• Device Sequence Number: 1
• Product Code: BYE
• UDI-Device Identifier: 15019517160215
• UDI-Public: 15019517160215
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/905/340-CH
• Device Lot Number: 230301
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/29/2023
• 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
• Patient Outcome(s): Required Intervention