MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ANESTHSIA BREATHING BAG, 3L, 22MM; CIRCULATOR, BREATHING-CIRCUIT

Model Number 670003

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)

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

Event Date 02/24/2024

Event Type  malfunction  

Manufacturer Narrative

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 anesthesia bag had a hole and leaked, so it could not be used." this occurred upon removal from package.No patient involvement and no harm/adverse event reported.Reported item number: ca24e0/4p6/000jp and reported lot number: 231228.Received component item number: (b)(4) and received component lot number: 4442745.

Manufacturer Narrative

H3 and h6.Evaluation codes: updated.Device evaluation: one (1) device sample was received without the original package.Five photos were included for evaluation; a hole was observed in the bag breathing.Per visual inspection, hole was detected in breathing bag, complaint was confirmed.The cause was unknown.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The complaint fault has been escalated to address a full root cause investigation.

• Brand Name: PORTEX ANESTHSIA BREATHING BAG, 3L, 22MM
• Type of Device: CIRCULATOR, BREATHING-CIRCUIT
• 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: 19034524
• MDR Text Key: 339271682
• Report Number: 3012307300-2024-02003
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• 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: 05/01/2024

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: Other
• Device Model Number: 670003
• Device Catalogue Number: 670003---802
• Device Lot Number: 4442745
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/28/2024
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2023
• 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