MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,7.5",EXP KT,-,OQ,5; CATHETERS

Model Number PM050-A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.(b)(6) 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).

Event Description

A report was received stating the surgeon was unable to remove the device from the patient and decided to cut the catheter.The patient under went a total abdominal hysterectomy with another surgeon while the primary surgeon was on leave.When the patient went to primary surgeon's office for catheter removal, the surgeon met resistance during removal of the device.Further pulling on the catheter made the catheter stretch.The surgeon then cut the catheter at the length that hung outside the patient and planned to later remove the remaining attached catheter.The catheter area was cleansed with chlorohexidine and covered with a tegaderm.The patient was instructed to return on thursday.Additional information received (b)(6) 2016 stated the patient returned to the surgeon's office on (b)(6) 2016.The care provider attempted to remove the catheter following the instruction on technical bulletin, (b)(4), preventing catheter breakage with on-q.The catheter broke and a segment of catheter of unknown length was left inside the patient.The surgeon decided to leave the catheter remnant in the patient and not to remove it at that point.The patient was instructed to report any symptoms to the surgeon, so further decision will be made then.The removed partial catheter was discarded.No additional information was provided in regards to the patient's status.

• Brand Name: SURGPN,7.5",EXP KT,-,OQ,5
• Type of Device: CATHETERS
• 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, b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5593410
• MDR Text Key: 43157323
• Report Number: 2026095-2016-00031
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: PM050-A
• Device Catalogue Number: 101354100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 60