MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,1",EXP KT,-,OQ,5; ON-Q PAIN BUSTER KIT

Model Number PM030

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the device was not returned and the lot number is unknown but a stock code was provided.Results: there are no testing results available as the investigation is currently in progress.Conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

Event Description

Procedure: block.Cathplace: asku.It was reported that during a nerve block procedure the catheter was found to be broken while the crna was adding dressing to the introduction site.There was no harm to the patient.Additional information was received on (b)(6) 2015: the crna reported that the catheter appeared kinked and the catheter break was noticed when tunneling under the skin.The catheter appeared cleanly cut and the crna was unsure how the cut could have occurred.A new product was used with the same lot number and the procedure was completed without further incident.

• Brand Name: SURGPN,1",EXP KT,-,OQ,5
• Type of Device: ON-Q PAIN BUSTER KIT
• 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-18; tijuana, b.c. 22116 ; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5246586
• MDR Text Key: 32208513
• Report Number: 2026095-2015-00324
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/26/2015

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
• Device Operator: Nurse
• Device Model Number: PM030
• Device Catalogue Number: 101353600
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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