MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PAIN RELIEF SYSTEM WITH DUAL SILVERSOAKER ANTIMICROBIAL CATHETERS

Model Number PS12508-A

Device Problem Material Fragmentation (1261)

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

Event Date 02/07/2022

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned and the investigation remains in progress at this time.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 2022 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.

Event Description

It was reported that upon removal of the catheter from the patient the tip was discovered to be missing.A ct scan and ultrasound were performed, however they were unable to find the missing piece of catheter inside the patient.There was no injury reported.Per additional information received 9 feb 2022, the patient's condition is stable.The patient was receiving ropivacaine 2mg/ml in saline.

Manufacturer Narrative

Correction: per review of the record it was determined that the original alert date was 7 feb 2022, not 8 feb 2022 as originally reported in g3 of the initial report.The device history record for lot 30100686 was reviewed and the product was produced according to product specifications.One used broken catheter was returned for evaluation.Examination of the catheter revealed that the tubing exhibited significant stretching and was severed approximately 12cm below a solid black depth marker.As this area is included in the stretching, this measurement may not represent the true distance from the marker.The severed end was examined under magnification.The end was jagged and did not appear as a cut.The complaint is confirmed as reported, however, no definitive root cause could be determined.All information reasonably known as of 08 apr 2022 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: ON-Q PAIN RELIEF SYSTEM WITH DUAL SILVERSOAKER ANTIMICROBIAL CATHETERS
• Type of Device: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 13587018
• MDR Text Key: 289681459
• Report Number: 2026095-2022-00008
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494136239
• UDI-Public: 00193494136239
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: 1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2023
• Device Model Number: PS12508-A
• Device Catalogue Number: N/A
• Device Lot Number: 30100686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ROPIVACAINE 2MG
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 61 KG