MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q ELASTOMERIC PUMP KITS; CATHETERS

Model Number	PM012-A
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a patient underwent shoulder surgery on (b)(6) 2026 and an on-q pain pump catheter was placed.Additional information was received on 02-apr-2026, reporting that during catheter removal on (b)(6) 2026, the patient¿s caregiver noted a ¿pop¿ and the catheter tip was missing.The patient subsequently underwent arthroscopic surgery on (b)(6) 2026 for removal of a retained catheter fragment (foreign body).The surgeon successfully retrieved the broken catheter tip, and it was noted that the retained segment contained a knot.The patient was reported to be doing well following the procedure.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for lot 30324379 was reviewed and the product was produced according to product specifications.A root cause could not be determined.All information reasonably known as of 20 apr 2026 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 reported event but is relaying the information 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 ELASTOMERIC PUMP KITS
• Common Device Name: 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. 22116 ; MX 22116
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 24932373
• Report Number: 2026095-2026-00030
• Device Sequence Number: 5357301
• Product Code: BSO
• UDI-Device Identifier: 10193494137011
• UDI-Public: (01)10193494137011(240)101370105(17)261129(10)30324379
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PM012-A
• Device Catalogue Number: PM012-A
• Device Lot Number: 30324379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 75 KG