MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,270X2D,PM025A,-,OQ,5; INCISIONAL PUMP KITS

Model Number PM025-A

Device Problems Break (1069); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the actual device was not returned.The lot number was not provided.A review of the device history record (dhr) was not performed.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.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).Device not returned.

Event Description

Procedure: anterior fusion.Cathplace: rectus sheath /preperitoneal space.The doctor stated that the patient had anterior fusion surgery in 2009.Two catheters were placed in the patient's rectus sheath /preperitoneal space.One of the catheters was removed, but the other was retained inside the patient.The patient reported some symptoms later on.The patient's healthcare provider was able to palpable the catheter inside the patient's scrotal area.The retained catheter was removed from the patient in (b)(6) 2014.The removed catheter appeared to be full length.The actual removed catheter was with the patient at the time.Additional information received from the physician on 20-apr-2016 stated the catheter was probably cut off by a nurse at removal or possibly dislodged from the connector.There was no evidence that the surgeon had difficulty inserting the catheter and it was not sutured through.It is unknown what kind of device was used to removed this catheter.There is no information of whether resistance was made during initial catheter removal.The patient's condition remained unchanged post incident.The retained catheter was removed from the patient on (b)(6) 2014.Additional information received on 26-apr-2016 stated bilateral on-q pain pump in abdomen along either side of the abdominal incision.When the pain pump was removed, the nurse didn't recognize that not all of the catheter was removed.This could be catheter break but not clear at that time.Procedure was in 2009.Catheter was not removed until 2014.It is believed that was that catheter remained retained and moved down to his scrotum.We don't know whether what they removed was actually the catheter (they/hos) think it was.Patient had multiple hospitalizations and radiology exams in between.No further information at this time.No additional information was provided.

Manufacturer Narrative

One sample silver soaker catheter segment was returned for evaluation.A visual analysis was performed.A caliper was used to measured the outer diameter of the catheter near the break which was 0.043inches a caliper was used to measured the length of the segment which was 9.11inches.Five kinks were observed in the catheter that were measured starting from the catheters' proximal end at 1.93, 5.15, 5.39, 5.670 and 7.67 inches.The broken end of the catheter was observed under magnification and it was noted that the catheter had been stretched/pulled causing the tubing to thin and then eventually break.The investigation summary concluded that a catheter break was observed due to the catheter being pulled.A total of five kinks were observed down the length of the approximately 9.11 inch catheter segment that was returned.The catheter tubing near the break was stretched out and thinned until it broke.The thinning was observed when viewing the catheter under magnification.Per the complaint description, there was no information of whether resistance was made during initial catheter removal, therefore, the root cause of the stretched catheter was unknown.All information reasonably known as of 03-jul-2018 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.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).

• Brand Name: SURGPN,270X2D,PM025A,-,OQ,5
• Type of Device: INCISIONAL PUMP KITS
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 5654501
• MDR Text Key: 45196686
• Report Number: 2026095-2016-00050
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: PM025-A
• Device Catalogue Number: 101371800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/13/2016
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other