MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX MANUAL RESUSCITATOR; CIRCULATOR, BREATHING-CIRCUIT

Catalog Number 670003

Device Problem Material Rupture (1546)

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

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

D4: lot number, expiration date, and h4: device manufacture date are unknown, no information has been provided to date.G5: 510 is unknown.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.

Event Description

It was reported that the device ruptured during use in an operation.The product had been checked before use and there was no problem.No patient harm/adverse event was reported.

Manufacturer Narrative

D9: date returned to mfg.: 1/3/2024.One device sample was received without the original package.Two photos were included for evaluation, and a broken bag was observed.Visual inspection confirmed the complaint.The root cause was not established.A device history record (dhr) review could not be performed as the lot number was unknown.The complaint fault has been escalated to address a full root cause investigation.

• Brand Name: PORTEX MANUAL RESUSCITATOR
• Type of Device: CIRCULATOR, BREATHING-CIRCUIT
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18306449
• MDR Text Key: 330565282
• Report Number: 9617604-2023-00011
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 670003
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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