MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q ANTIMICROBIAL EXPANSION KITS WITH SILVERSOAKER CATHETER 5 IN (12.5 CM); CATHETERS

Model Number	PM020-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 05-apr-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
Event or Problem Description
Fill volume: unknown, flow rate: unknown, procedure: abdominoplasty, cathplace: in wound before closing.It was reported two catheters were used and removal was attempted after the pumps were successfully emptied.The right catheter was easily removed; however, the patient experienced pain when the nurse attempted removing the left catheter.The patient was given pain relief and removal was attempted after an hour.The patient still experienced pain and the physician was notified.When the physician attempted removing the catheter it snapped with a segment of about 10cm remaining inside the patient.The surgeon was planning to leave the broken segment in-situ.The nurses reported the catheter felt tight and resistance was noted during removal.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 30-may-2019 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.
Additional Manufacturer Narrative
The device history record for the reported lot number0203066015, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One used pump with two select a flow (saf) dials and one silver soaker catheter attached.The catheter was received with a black thread tied around the outside.A set bend was observed in the catheter at the location of the thread.The tied thread was slid down the catheter to expose the area underneath.No breaks or cuts were observed in this area.The catheter was intact with no breaks or cuts.The black tip at the distal end was attached.The root cause was not established, since no defect was found in the received sample.All information reasonably known as of (b)(6) 2019 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.

• Brand Name: ON-Q ANTIMICROBIAL EXPANSION KITS WITH SILVERSOAKER CATHETER 5 IN (12.5 CM)
• Common Device Name: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8489645
• Report Number: 2026095-2019-00055
• Device Sequence Number: 13921065
• Product Code: BSO
• UDI-Device Identifier: 30680651135354
• UDI-Public: 30680651135354
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K051401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2021
• Device Model Number: PM020-A
• Device Catalogue Number: 101353500
• Device Lot Number: 0203066015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 05/07/2019; 06/11/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/31/2019; 07/05/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELASTOMERIC PUMP CB6007; ONE PUMP WITH TWO SELECT A FLOW (SAF) DIALS.