MAUDE Adverse Event Report: TELEFLEX MEDICAL GUEDEL AIRWAY CLEAR, RUSCHELIT; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOG

Model Number IPN915380

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that "the tubes of size 4 (yellow) are packed in packaging for tubes of size 3 (green).The batch number and expiry date match." the issue was identified when it was received.There was no patient involvement.

Event Description

It was reported that "the tubes of size 4 (yellow) are packed in packaging for tubes of size 3 (green).The batch number and expiry date match." the issue was identified when it was received.There was no patient involvement.

Manufacturer Narrative

Qn#(b)(4).The sample was not returned for investigation.The manufacturer reported: "soft quedel#8 order found soft guedel#9 included, checked up the production record of same lot.According to production record, we can eliminate the following concerns: 1.1 they are produced in different production line and different dates; 1.2 the outer boxes are all printed, and the printing boxes needs to be confirmed one by one before production.This means that the concern about mixing materials in the production line can be eliminated.In oqa, 2.1 oa member inspects one item (batch) at once and sealed the previous before continuing inspection for next item (batch).Both productions are inspected on different dates, which means the concern about mixing materials in oqa can be eliminated.According to the record, no reason found." teleflex will continue to monitor and trend on complaints of this nature.

Manufacturer Narrative

Qn # (b)(4).The sample was returned for investigation.The manufacturer reported: "soft quedel#8 order found soft guedel # 9 included, checked up the production record of same lot.According to production record, we can eliminate the following concerns: 1.1 they are produced in different production line and different dates; 1.2 the outer boxes are all printed, and the printing boxes needs to be confirmed one by one before production.This means that the concern about mixing materials in the production line can be eliminated.In oqa, 2.1 oa member inspects one item (batch) at once and sealed the previous before continuing inspection for next item (batch).Both productions are inspected on different dates, which means the concern about mixing materials in oqa can be eliminated.According to the record, no reason found." teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that "the tubes of size 4 (yellow) are packed in packaging for tubes of size 3 (green).The batch number and expiry date match." the issue was identified when it was received.There was no patient involvement.

• Brand Name: GUEDEL AIRWAY CLEAR, RUSCHELIT
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOG
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18719227
• MDR Text Key: 336641389
• Report Number: 3011137372-2024-00024
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2024

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: IPN915380
• Device Catalogue Number: 124700-000030
• Device Lot Number: 22/44/6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 03/25/2024; Not provided
• Supplement Dates FDA Received: 03/25/2024; 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2022
• 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
• Treatment: NOT REPORTED; NOT REPORTED; NOT REPORTED