MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,5",EXP KT,-,OQ,5; INTRODUCERS

Model Number PM020-A

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

The device history record for the lot number, 0202588182, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual complaint product was not returned for evaluation.Root cause could not be determined.Halyard health 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 halyard health complaint database and identified as complaint comp-(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 a halyard health product is defective or caused serious injury.

Event Description

Procedure: spinal surgery.A report was received stating a t-peel broke inside a patient.During t-peel removal the t-peel stretched and broke.About half of the t-peel was retained inside the patient.The surgeon decided to leave the broken t-peel inside the patient due to the potential of tearing the para spinal muscles.The surgeon pulled and peeled at the same time during the removal.The removed portion of the t-peel was stretched and curled.There was no reported patient injury.

Manufacturer Narrative

All information reasonably known as of 22-jun-2017 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 halyard health 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 halyard health.Halyard health 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 halyard health 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 a halyard health product is defective or caused serious injury.

• Brand Name: SURGPN,5",EXP KT,-,OQ,5
• Type of Device: INTRODUCERS
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, bc
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6446621
• MDR Text Key: 71481445
• Report Number: 2026095-2017-00045
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10680651135350
• UDI-Public: 10680651135350
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 05/14/2019
• Device Model Number: PM020-A
• Device Catalogue Number: 101353500
• Device Lot Number: 0202588182
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 86