MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. ABC ST E87 3L 30 NS + 20/CA; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C45101344-NLJ

Device Problems Crack (1135); Gas/Air Leak (2946)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that during testing a cracked anesthesia bag tip was found and air leakage occurred.The event occurred in early (b)(6) 2024.The sample was available for return.There was no patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

B3: month and year of event have been provided, day is unknown.E1: initial reporter: person is charge at facility is (b)(6); no other information for true initial reporter available at this time.G5: 510k is blank, the product code is exempt.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

Supplemental generated to correct supplemental emdr-17704; previous emdr submitted by brenan cain.G6 type of report: follow-up 30 day.

Manufacturer Narrative

D9 date returned to mfg: 2/9/2024.Three photos depicting the device and one sample device were received for investigation.In one photo, a cut is depicted on the device bag.The reported issue was confirmed during visual inspection, which identified a cut on the bag of the sample device.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Based on the available information, the investigation confirmed the reported issue, however, no manufacturing-related root cause could be established.Complaint data will continue to be monitored and actions assigned accordingly.

• Brand Name: ABC ST E87 3L 30 NS + 20/CA
• 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: 18669592
• MDR Text Key: 335309802
• Report Number: 9617604-2024-00110
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 03/27/2024

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 Catalogue Number: C45101344-NLJ
• Device Lot Number: 4406718
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/18/2024
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 01/12/2024; 01/12/2024
• Supplement Dates FDA Received: 03/26/2024; 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2023
• 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