MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN ONQ PUMP WITH CATHETERS

Model Number UNKNOWN

Device Problem Material Fragmentation (1261)

Patient Problems Pulmonary Embolism (1498); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440); Peripheral Edema (4578)

Event Date 09/22/2021

Event Type  Injury  

Event Description

It was reported by the patient's daughter that following her mother's hysterotomy, she received a pain pump with two catheters placed at the surgical site.Upon removal several days later, one of the catheters broke, leaving a piece behind inside the patient.Based on comparison with the other catheter, she believes at least 5 inches remain in the patient's abdomen.A ct with contrast was performed, however, the fragment could not be visualized.Per additional information received 08 oct 2021, the patient's daughter reports that her mother received a total abdominal hysterectomy on (b)(6) 2021 at houston methodist sugar land hospital and was discharged with an onq pump on (b)(6) 2021.They were told that the catheters could be removed on (b)(6) 2021, however they were provided no instructions on how to do so by the hospital.Upon removal, one broke inside the patient, the other was removed without incident.The patient returned to the hospital on (b)(6) 2021 for "two pulmonary embolisms and severe swelling in arm, and blood clots," however she does not know if those incidents were related to the catheter break.The patient was treated with blood thinners and "other meds" and released home.At the time of this call, the patient was recovering at home.

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.Photos of the device were provided by the patient's mother.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 21 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.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).

Manufacturer Narrative

A catheter with missing black tip was returned for evaluation.Visual examination revealed that the catheter was stretched in appearance, starting at 48cms.The complaint is confirmed as reported, however, no root cause could be determined.All information reasonably known as of 16 nov 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: UNKNOWN ONQ PUMP WITH 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: 12682358
• MDR Text Key: 281281448
• Report Number: 2026095-2021-00100
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female