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 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3: month and year of event have been provided, day is unknown.D4: exact lot number, expiration date, udi, and h4: manufacture date cannot be determined as 2 possible lot numbers have been identified.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, making it unusable." this occurred upon removal from package.No patient involvement and no harm/adverse event reported.Possible lot numbers: 4400497 or 4403670.

Manufacturer Narrative

H3 and h6 - evaluation codes: updated.Device evaluation: five photos were included for evaluation; a hole was observed in the bag breathing.One (1) sample was received without the original package.Per visual inspection, hole was detected in breathing bag, complaint was confirmed.This issue will continue to be monitored and further actions taken accordingly to determine the root cause.A review of the device history records (dhr) for both possible reported lot numbers, show there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with either lot of products.

• 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: 19028586
• MDR Text Key: 339223073
• Report Number: 3012307300-2024-01989
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

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 Model Number: 670003
• Device Catalogue Number: 670003---802
• Device Lot Number: UNCERTAIN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/28/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 05/01/2024
• 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