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

Model Number PL19100GC

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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.

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 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.".

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
• Type of Device: REGIONAL ANESTHESIA
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9257161
• MDR Text Key: 214580771
• Report Number: 2026095-2019-00180
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30680651327711
• UDI-Public: 30680651327711
• Combination Product (y/n): N
• PMA/PMN Number: K102007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/20/2019
• Patient Sequence Number: 1