MAUDE Adverse Event Report: AVANOS MEDICAL INC. AVANOS STRAIGHT RF CANNULA, RADIOPAQUE MARKER; STANDARD RF PROBES AND CANNULAS

Model Number PMF22-100-5

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is in-progress.The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of 07 jul 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).

Event Description

It was reported that during the use of the rf [radiofrequency] needle, the platinum ring on the tip of the needle was retained in the patient.The procedure was a sig [sacroiliac joint] demonstration.According to the customer, "no special manipulations were made," and "conservative treatment was used." additional information received 17-jun-2021 indicated the platinum ring was not removed from the patient.Additional information has been requested but not yet received.

Manufacturer Narrative

The actual complaint product was returned for evaluation.The investigation remains in progress.All information reasonably known as of 17 aug 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

Manufacturer Narrative

The sample involved in the reported event was evaluated.It was determined that the missing component referred to as "platinum ring" in the complaint, is actually "item no.5: pt band," and that in the affected sample, the pt band was missing.Per a review of the manufacturing process it was determined that this was a manufacturing issue.The device history record for lot 30109113 was reviewed and the product was produced according to product specifications.All information reasonably known as of 26 oct 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: AVANOS STRAIGHT RF CANNULA, RADIOPAQUE MARKER
• Type of Device: STANDARD RF PROBES AND CANNULAS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12131800
• MDR Text Key: 266423487
• Report Number: 8030647-2021-00022
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 00193493986453
• UDI-Public: 00193493986453
• Combination Product (y/n): N
• PMA/PMN Number: K972846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PMF22-100-5
• Device Catalogue Number: N/A
• Device Lot Number: 30109113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR