MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PAIN RELIEF SYSTM, SELECT-A-FLOW, 400ML; ELASTOMERIC - SAF

Model Number CB004

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Pain (1994); Numbness (2415); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

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 in-progress.All information reasonably known as of 31-mar-2023 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

Fill volume: unknown.Flow rate: unknown.Procedure: shoulder surgery.Cathplace: unknown.It was reported "when the catheter was placed, i expressed concern that i still felt sensations in my left fourth and fifth finger and not complete numbness in the hand.I experienced quite a bit of pain post-op and the ball was completely empty after two days.For the last two days, i have been having severe muscle cramps in my back and arm in the surgery area.It seems as if the pain medication leaked out too quickly." there was no reported injury.Additional information received and the user states "that he is very suspicious about the anesthesiologist's technique of inserting the catheter (she's new, and it took her a long time; after i told her it didn't feel right, she told me they would worry about that later.' patient states "it is not your product, ok? i really think they messed up where they put it." at the time of call patient's symptoms were not present.Denies anything further than what was originally reported.Asked patient if he contacted the physician, he said "heck no, they don't care." advised him to contact the physicians and anesthesia to notify them of the issue.

Manufacturer Narrative

Additional information: d1, d2, d4 and g4 correction d4: lot number all information reasonably known as of 02-may-2023 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

The device history record for the reported lot number, 30198569, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The pump was received empty, with the pinch clamp present and open.The fill port cap is attached.There was no cap on the distal luer.There was no visible crystallization or discoloration on the filter.The tubing was intact, with no visible damage.The select-a-flow (saf) was set to 6ml/hr.The dial was not present.The cover was secured with the zip tie.The device was evaluated.When tested without the filter, the sample yielded results that were within specification at all tested saf settings.During the sample evaluation, the reported incident was not replicated.The flow rate accuracy testing was performed with the saf set to 14 ml/hr and the pump yield a flow rate within specifications.Per instructions for use (ifu) the flow rate of a pump could be affected by different external factors as filling the pump more than the labeled fill volume, the increase of temperature, the pump position and addition of some drugs or the use of another diluent may change viscosity and increase the flow rate which are potential causes for the fast flow during the use of the device.Root cause could not be determined.All information reasonably known as of (b)(6) 2023 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 PAIN RELIEF SYSTM, SELECT-A-FLOW, 400ML
• Type of Device: ELASTOMERIC - SAF
• 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: 16666717
• MDR Text Key: 312596472
• Report Number: 2026095-2023-00044
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494134723
• UDI-Public: 00193494134723
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• 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,Followup
• Report Date: 06/07/2023

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: Lay User/Patient
• Device Model Number: CB004
• Device Catalogue Number: N/A
• Device Lot Number: 30198569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 04/05/2023; 05/11/2023
• Supplement Dates FDA Received: 05/02/2023; 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• 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
• Treatment: UNKNOWN CATHETER.; UNKNOWN MEDICATION INFUSION.
• Patient Outcome(s): Other
• Patient Sex: Male