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

Catalog Number	100/905/340-CH
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Event or Problem 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".
Additional 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.
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record could not be completed as no lot number was received.
Additional Manufacturer Narrative
On review of the file, it was found that it was entered on the incorrect record type.On further review it was determined that the device does not have a 510k or sales in the united states.Nor are there any substantially similar devices sold in the us.Therefore, no regulatory reporting is required.Please disregard any reports associated with file mrn 3012307300-2023-12280.

• Brand Name: PNEUPAC DISPOSABLE CIRCUITS
• Common Device Name: 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
• Report Number: 3012307300-2023-12280
• Device Sequence Number: 20520953
• Product Code: BYE
• UDI-Device Identifier: 15019517160215
• UDI-Public: 15019517160215
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 100/905/340-CH
• Device Lot Number: 230301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 11/29/2023; 06/11/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 08/06/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown