MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE PROLONG CONTINUOUS NERVE BLOCK SET; REGIONAL ANESTHESIA

Model Number	PL19100GC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 30-oct-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.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
It was reported that while the doctor was placing the catheter, the needle cracked in half.There was no injury to the patient, and the physician used another catheter kit to continue and complete the procedure.
Additional Manufacturer Narrative
All information reasonably known as of 20-nov-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.
Event or Problem Description
Additional information received 31-oct-2019 stating "the patient was stuck with the needle that broke.It didn't break close to the insertion site and was removed easily.".
Additional Manufacturer Narrative
The device history record for the reported lot number, 0002967057, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One needle with protective plastic sheath and opened product packaging was returned.The needle is severed 4.1 cm from the distal tip.The beveled distal tip was present and appeared undamaged.The device was examined under magnification and from varying angles.The broken ends were jagged and appeared pinched or compressed.A root cause was not established.All information reasonably known as of 15-jan-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.

• Brand Name: PROLONG CONTINUOUS NERVE BLOCK SET
• Common Device Name: REGIONAL ANESTHESIA
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9257161
• Report Number: 2026095-2019-00180
• Device Sequence Number: 16568865
• Product Code: CAZ
• UDI-Device Identifier: 30680651327711
• UDI-Public: 30680651327711
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K102007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2022
• Device Model Number: PL19100GC
• Device Catalogue Number: 103277103
• Device Lot Number: 0002967057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/31/2019; 12/20/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/21/2019; 01/16/2020
• Patient Sequence Number: 1