MAUDE Adverse Event Report: AIRGAS THERAPEUTICS LLC ISPAN GAS TANK REGULATOR; INTRAOCULAR GAS

Catalog Number 8065797303

Device Problems Gas Output Problem (1266); Defective Component (2292)

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

Event Date 05/19/2022

Event Type  malfunction  

Manufacturer Narrative

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.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during a vitrectomy procedure an ophthalmic regulator knob was fallen off and it could not dispense the perfluropropane (c3f8).The procedure was completed using silicone oil for the patient.There was no harm to the patient.

Manufacturer Narrative

Additional information was provided in sections h.6 and h.10.With the information provided, the customers¿ reported event was not able to be confirmed.A check of the batch production record for this lot, showed no unusual manufacturing issues.A check of the complaint records showed (b)(4) complaints against the same lot number.A check of confirmed complaints showed (b)(4) similar complaints.There was no sample returned for this investigation.With no additional, related information provided, the customer reported event was not confirmed.Based upon the information obtained, the root cause cannot be determined conclusively.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: ISPAN GAS TANK REGULATOR
• Type of Device: INTRAOCULAR GAS
• Manufacturer (Section D): AIRGAS THERAPEUTICS LLC; 6141 easton road; p.o. box 310; plumsteadville PA 18949
• Manufacturer (Section G): AIRGAS THERAPEUTICS LLC; 6141 easton road; p.o. box 310; plumsteadville PA 18949
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14679394
• MDR Text Key: 294410122
• Report Number: 1610287-2022-00043
• Device Sequence Number: 1
• Product Code: LPO
• UDI-Device Identifier: 00380657973033
• UDI-Public: 00380657973033
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P900066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065797303
• Device Lot Number: 104323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1