MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX ANESTHESIA BREATHING CIRCUIT, CORRUGATED; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C37101329-NLJ

Device Problems Fracture (1260); Gas/Air Leak (2946)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that during testing there was a leak from the anesthesia bag.The anesthesia bag was torn and there was a leak from it.The event occurred in (b)(6) 2023.There was no patient harm/adverse event reported.Possible reported lot numbers were 4393842 or 4393838.

Manufacturer Narrative

B3: month and year of event have been provided, day is unknown.D4: expiration date and h4: manufacture date are unknown as the exact lot number of the involved device is unknown.G5: 510k is blank, this product code is 510k exempt.H3 - other: device has not been returned to date.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.

Manufacturer Narrative

D9: date returned to mfg.: 1/8/2024.H3 and h6.Evaluation codes: updated.Device evaluation: one device sample without original package was received.Two photos were also received.Per visual inspection, a hole was detected in the breathing bag.The complaint was confirmed.A device history record (dhr) review could not be performed as the lot number was unknown.Based on the analysis conducted the breathing bags present a damage, root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly process.The complaint fault has been escalated to address a full root cause investigation.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT, CORRUGATED
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• 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: 18440145
• MDR Text Key: 331879081
• Report Number: 9617604-2024-00004
• Device Sequence Number: 1
• Product Code: CAI
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: C37101329-NLJ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2024
• 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