MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,ON-Q-TBLOC,CENBS,-,3.5 IN,10; REGIONAL ANESTHESIA

Model Number TBT01089T

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: a review of the device history record is not possible as no lot number was provided.The actual complaint product was returned for evaluation.Results: one sample device was returned.The product did not contain a lot number identification.The sample was identified as a proximal segment of an epimed spirol catheter with a black insertion mark on one end of the catheter.No other section of the catheter was returned.There was a kink observed near the distal end of the catheter section.Using a pair of calipers, the catheter segment measured approximately 5.9 inches.The kink was measured at approximately 4.9 inches from the proximal end of the catheter.The distal end was examined under magnification and the end of the catheter appeared to be sheared or cut.Conclusions: once the investigation is completed a follow-up report will be submitted.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.

Event Description

Procedure: total knee arthroplasty.Cathplace: unknown.A report was received stating the catheter was broken in two places.The catheter broke closest to the sting ray section of the device.The device was not retained in the patient.There was no report of patient injury.Additional information received on (b)(6) 2016 stated the nurse anesthetist noticed that the catheter was in two pieces.The nurse anesthetist assumed it was cut by someone but was unsure and later thought it may have been broken in two pieces.He was not the anesthesiologist that inserted the catheter and therefore; could not provide information on the patient or the date of the procedure.The nurse anesthetist did knot now when the catheter was removed.The nurse anesthetist stated that there was no patient injury or additional medical intervention needed as a result of this incident.No further information to be provided.

• Brand Name: SURGPN,ON-Q-TBLOC,CENBS,-,3.5 IN,10
• Type of Device: REGIONAL ANESTHESIA
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S DE RL DE CV; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5536934
• MDR Text Key: 41719973
• Report Number: 2026095-2016-00024
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111355
• 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: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: TBT01089T
• Device Catalogue Number: 103272300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1