MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q CATHETERS-SILVERSOAKER

Model Number PM010-A

Device Problem Break (1069)

Patient Problems Bacterial Infection (1735); Foreign Body In Patient (2687)

Event Date 03/26/2022

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 04 may 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 a portion of a silver soaker catheter was retained inside of the patient; a computed tomography scan (ct) abdomen/pelvis was performed and read as no findings.There was no reported injury.Additional information received 11apr2022 reported that the catheter was secured with tegaderm only and the patient did not express that any resistance was met during insertion or removal of the catheter, an xray of the abdomen, pelvis and chest were performed.The patient was reportedly in stable condition; there was no reported injury.Additional information received 02may2022 the patient reported that they were on several antibiotics due to redness and drainage from the incision site on the right side of the abdomen and belly button.Cultures performed on the drainage, during a routine post-op visit revealed the growth of pseudomonas stutzeri and prevotella oralis, the patient was prescribed antibiotic treatment over the past month.The patient reported that the incision site drainage and redness had improved and there was no fever or other serious signs of infections.The patient reportedly was very worried that the distal portion of the catheter remained inside of the patient and was the cause of their "infection".A magnetic resonance imaging (mri) was scheduled for further testing regarding the catheter.

Manufacturer Narrative

The actual sample from the reported event was returned for evaluation.Visual examination of the device revealed the hub was securely attached at the proximal end of the catheter and there were no kinks or crimps in the partial catheter tubing.The severed end was examined under magnification, the end appeared somewhat pinched, with a more oval shape.There was a crusty, white residue at the edges.The reported event could be confirmed as reported; however, the root cause is undetermined.All information reasonably known as of 21 jun 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 CATHETERS-SILVERSOAKER
• Type of Device: CATHETER
• 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: 14315959
• MDR Text Key: 299762999
• Report Number: 2026095-2022-00049
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 00193494135331
• UDI-Public: 00193494135331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM010-A
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 77 KG