MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PUMP: SILVERSOAKER 5IN 270ML, 4ML (2+2 DUAL); ELASTOMERIC PUMP KIT

Model Number PS12505-A

Device Problems Material Fragmentation (1261); Kinked (1339)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/17/2015

Event Type  Injury  

Event Description

Procedure: asku cathplace: asku an international distributor reported a t-peel sheath break during use on a patient.It was reported as, the "white cover snapped".The pump and catheter from the kit were used on the patient.The sample is not available for return, however photographs were provided by the reporter.Additional information was provided on (b)(6) 2015.The t-peel broke during use.A small incision was necessary to retrieve the t-peel from inside the patient.The removal was performed in the operating room during the time of the initial procedure.Additional information was requested, however is not available at this time.

Manufacturer Narrative

(b)(4).Method code: actual device not evaluated method: the sheath was not available for return; however, a photographic inspection was performed.A review of the device history record (dhr) was conducted for the lot number reported.Results: as the device was unavailable for analysis, no device testing methods were performed.For this reason device testing results cannot be obtained.However, the photographic inspection indicated that the t-peel sheath is in 3 pieces.The t-peel sheath appears to be broken halfway down into an upper and a lower portion of the sheath.The upper portion of the t-peel sheath appears to be peeled away into two pieces at the top third portion of the sheath.The t-peel sheath cover appears kinked halfway.The instructions for use (ifu) (14-60-602-0-02) specifies, "caution: 7.Caution: while holding catheter tip (1), withdraw sheath completely from puncture site prior to splitting to avoid sheath breaking off in patient (2).Split sheath and peel away from catheter (3) (figure 6 on page 6)." the dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.Conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.Photographic inspection indicated that the t-peel sheath was broken into an upper portion and a lower portion and peeled away into a third piece at the upper third portion of the t-peel sheath.Additionally, the t-peel sheath cover appears kinked halfway.Limited information was provided by the reporter.Multiple attempts were made to obtain additional information without success.The ifu specifies, "caution: 7.Caution: while holding catheter tip (1), withdraw sheath completely from puncture site prior to splitting to avoid sheath breaking off in patient (2).Split sheath and peel away from catheter (3) (figure 6 on page 6)." per the dhr, the lot met the process specifications, including the quality control acceptance criteria prior to release.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.

Manufacturer Narrative

Methods: it was previously reported that the device was unavailable for return and analysis.However, the actual device was returned and was received with a black pouch with a lot number different from what was originally reported.Clarification was received that the lot number found on the pouch is the lot number, 0201156213, for the suspect device.A visual inspection was conducted.A review of the device history record (dhr) and a process review were conducted for the reported model and lot number.Results: the t-peel #1 and #2 were received in two pieces.The t-peel was broken at the hub and the sheath was still intact on both of the hubs.The lot met the process specifications, including the quality control acceptance criteria prior to release.The process review, which includes visual and functional inspections, indicates that the lot was manufactured according to approved procedures.Conclusions: the investigation concluded that broken t-peel #1 and #2 were observed.The units were not full intact; both of the hubs were still connected to the sheaths.It was reported that there the doctor experienced difficulty withdrawing the sheath after the catheter insertion.Therefore, the physician used a scalpel to assist in withdrawing the sheath, which may explain why the hubs were still connected to the sheaths.However, no root cause could be identified for the reported incident.As previously reported, the instructions for use (ifu) specifies, "caution: while holding catheter tip 1, withdraw sheath completely from puncture site prior to splitting to avoid sheath breaking off in patient 2.Split sheath and peel away from catheter." 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.

• Brand Name: ON-Q PUMP: SILVERSOAKER 5IN 270ML, 4ML (2+2 DUAL)
• Type of Device: ELASTOMERIC PUMP KIT
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4728396
• MDR Text Key: 20808194
• Report Number: 2026095-2015-00135
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2016
• Device Model Number: PS12505-A
• Device Catalogue Number: 101362100
• Device Lot Number: 0201156213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention