MAUDE Adverse Event Report: HALYARD - IRVINE HYHSURGPN,400X2D,P.ONLY,-,OQ,5; ELASTOMERIC LFR

Model Number P400X4D

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/03/2017

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product is reported to be available but has not been received for evaluation.A review of the device history record is in-progress.All information reasonably known as of 03-jan-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.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.(b)(4).

Event Description

Fill volume: unknown, flow rate: unknown, procedure: c-section, cathplace: abdomen.It was reported that an attempt was made to remove the patient's onq pump prior to their discharge.However, the registered nurse encountered difficulty with the removal.The surgeon made an attempt at removal, but the tip broke off and remained in the patient's abdomen.The patient, consequently, required surgery for the removal of the broken catheter tip.Additional information received on 26-dec-2017 stated that the patient was admitted to the hospital on (b)(6) 2017 for a cesarian section.The onq pump was placed while in surgery for pain management.The catheter broke off in the abdomen on (b)(6) 2017.The actual removal of the catheter began with the previous pfannenstiel incision which was opened with a kelly clamp.The sutures holding the fascia were cut.The patient¿s ultrasound that was done previously was placed on the viewing screen and it appeared that the catheter tip may be located within the subcutaneous layer.The area was evaluated with the fascia beneath the catheter¿s insertion site incised to help with the evaluation.The tip was not visible.The sutures holding the muscles were then cut.The catheter tip was found and removed.There was no reported patient injury.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 15-jan-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).

Manufacturer Narrative

The product involved in the report has been received.Approximately an inch of the distal infusion catheter section was returned for evaluation.It was examined under magnification and found at the proximal end that the catheter was thinner and had signs it was stretched.Tensile strength was performed on the catheter infusion segment using the instron machine.The passing rate for the test is >2.8(lbf) at the infusion segment and >4.00 (lbf) for the mid-body segment.The result for the infusion segment was 4.630(lbf).The mid-body segment was unable to be performed because it was not returned.The catheter infusion segment met specifications during the tensile test and no additional testing was performed.The investigation summary concludes that the silver soaker catheter was received not fully intact, missing all of the catheter proximal to the very last black marking designating the infusion section.Evidence revealed that stretching was observed at the breakage.Tensile strength was performed on the infusion segment and met specifications.Excessive force failure mode was chosen because during visual observation of the catheter, stretching and breakage was observed.Tensile strength on the mid-body met specifications.Using excessive force >4.00(lbf) on the catheter at the mid-body segment and >2.8(lbf) at the infusion segment will cause it to break.The device history record for the lot number, 0202753380, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.No root cause was identified.All information reasonably known as of 21feb2018 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: HYHSURGPN,400X2D,P.ONLY,-,OQ,5
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7161984
• MDR Text Key: 96712100
• Report Number: 2026095-2018-00001
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651136764
• UDI-Public: 30680651136764
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2018

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: Physician
• Device Expiration Date: 12/25/2019
• Device Model Number: P400X4D
• Device Catalogue Number: 101367603
• Device Lot Number: 0202753380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 01/10/2018; 02/21/2018
• Supplement Dates FDA Received: 01/17/2018; 03/02/2018
• Patient Sequence Number: 1
• Patient Age: 31 YR