MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM WITH DUAL SILVERSOAKER ANTIMICROBIAL CATHETERS, 270 ML

Model Number PM015-A

Device Problems Break (1069); Stretched (1601)

Patient Problem No Code Available (3191)

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 03-mar-2020 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, inc.Complaint database and identified as (b)(4).

Event Description

Avanos medical received a single report that referenced three different incidences, which were associated with separate units, involving three different events.This is the first of three reports.Refer to 2026095-2020-00030 for the second event.Refer to 2026095-2020-00031 for the third event.Fill volume: unknown.Flow rate: unknown.Procedure: caesarian section (c-section).Cathplace: unknown.It was reported the catheter "snapped off" in the patient¿s c-section wound.The catheter stretched and snapped.The "snapped off" part was retrieved.Additional information received 10-feb-2020 stated the report on the initial removal attempt noted resistance was experienced with the continued attempt to remove the catheter.The catheter stretched and then snapped apart.The patient returned to the operating room (or) for removal of the catheter tip from the subcutaneous space.There was no injury related to retrieval of the broken catheter tip.

Manufacturer Narrative

The device history record for the reported lot number, 0002986472, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 28-may-2020 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

All information reasonably known as of 11-mar-2020 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.

Event Description

Additional information received 10-mar-2020 stated medical intervention was required.The patient received surgery under spinal block anesthesia to recover the broken tube on (b)(6) 2020 at 1905.The tube was successfully removed.The patient was discharged on (b)(6) 2020.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH DUAL SILVERSOAKER ANTIMICROBIAL CATHETERS, 270 ML
• Type of Device: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9782046
• MDR Text Key: 217987328
• Report Number: 2026095-2020-00029
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10680651137132
• UDI-Public: 10680651137132
• Combination Product (y/n): N
• PMA/PMN Number: K051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2021
• Device Model Number: PM015-A
• Device Catalogue Number: 101371303
• Device Lot Number: 0002986472
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 03/10/2020; 05/06/2020
• Supplement Dates FDA Received: 04/05/2020; 05/29/2020
• Patient Sequence Number: 1
• Treatment: ANALGESIC
• Patient Age: 24 YR
• Patient Weight: 76