MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 7FR X 25CM

Model Number 756507025

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 07/24/2023

Event Type  malfunction  

Manufacturer Narrative

According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.

Event Description

Usage process: usage: during drainage, the joint of the puncture tube is not tightly sealed, and there is air leakage during suction.Adverse event situation: the joint of the puncture tube is not tightly sealed, and air leakage during suction affects the victim.Treatment measures taken: (b)(6) 2023.Treatment measures taken: block the air leakage artificially.Adverse event improvement time: (b)(6) 2023.

• Brand Name: SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 7FR X 25CM
• Type of Device: SKATER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 17596074
• MDR Text Key: 321665827
• Report Number: 0001625425-2023-01167
• Device Sequence Number: 1
• Product Code: GBQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2023

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: 756507025
• Device Lot Number: 11440072
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention