MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PAIN RELIEF SYSTEM SILVERSOAKER 5IN(12.5CM): 270 ML, 4ML/HR (2+2 DUAL SITE); ELASTOMERIC PUMP

Model Number PS12505-A

Device Problems Split (2537); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2015

Event Type  malfunction  

Event Description

Procedure: asku.Cathplace: asku.An international distributor reported that a facility in the (b)(6) had 2 catheters that broke on a dual catheter device.It was reported as follows: "part of catheter broke off" and "damage-tear off".No patient injury nor medical intervention was reported.Additional information was requested, however is not available at this time.The device is available for return and photographs were provided.

Manufacturer Narrative

(b)(4).Method: the device was received for analysis.A visual inspection and a review of the device history record (dhr) were performed.Results: there are no testing results available as the investigation and evaluation are currently in progress.However, 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: once the analysis and investigation are completed a follow-up report will be submitted.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: along with the previously reported methods, a tensile strength test was performed.Results: a visual inspection found two silversoaker catheters returned for evaluation, each attached to a line of a dual line pump.Catheter #1: a visual inspection found the catheter returned in two pieces.The catheter was examined for signs of brittleness and none were found.The catheter was broken between the third and second catheter marking.A kink was found between the second and first catheter marking.A second kink was found at the beginning of the infusion segment and a third kink/partial break was near the distal tip of the catheter.A digital caliper was used to measure the catheter break which was approximately 0.630 inches distal to the third catheter marking.The diameter of the catheter at the third marking was measured at 0.041 inches.The diameter at the end of the tubing from the break at the side of the second marking was 0.040 inches.A second kink (beginning of infusion segment) measured approximately 0.201 inches distal do the second marking.The catheter diameter near the distal tip kink/partial break measured 0.039 inches.The ends of the catheter where the break occurred were examined under magnification.The break does not dissect directly across the catheter.The break occurred with the base section of the break having a larger diameter.The cut then runs diagonally across as the tubing decreases to one side.The remaining distal side of the break is a thin longitudinal section of the tubing.A portion of the catheters outer diameter is flat proximal to the break indicating that the catheter may have been cut with a sharp object as the tubing was in a loop or slightly curved.Catheter #2: a visual inspection found the catheter was returned in two pieces.The catheter was examined for signs of brittleness and none were found.A break was found between the first marking and the infusion segment marking.The diameter of the catheter section on the proximal side of the break was measured at 0.025 inches.The diameter of the catheter at the distal side was 0.034 inches.The catheter at the third marking was measured at 0.040 inches.The second marking was measured at 0.40 inches.At 0.816 inches distal to the second catheter marking the diameter changed to 0.0365 inches.The catheter diameter near the proximal tip measured 0.0255 inches.The catheter ends near the break were examined under magnification.Each end shows signs of the catheter being stretched.Tensile strength testing was performed on catheter #1.The result of the infusion segment was 4.27(lbf).The result of the mid-body segment was 8.81(ibf).Tensile strength testing was performed on catheter #2.The result of the infusion segment was 4.46(lbf).The result of the mid-body segment was 9.18(ibf).Conclusions: the investigation summary concluded that both catheters #1 & 2 met the tensile strength testing specifications.Based on the investigation the catheters were damaged, (likely due to excessive force) and cut (using a sharp object).For catheter #1 measurements of the catheter diameter indicate that the catheter was stretched starting distal to the second marking.The catheter's tubing edges indicates that a sharp object was used to cut the catheter.For catheter #2 measurements of the diameter indicate that the catheter was stretched at the infusion segment.Analysis of the broken catheter ends found signs that the catheter was pulled.Based on the investigation performed the complaint is considered confirmed.The instructions for use (ifu) provides a caution regarding catheter removal-if resistance is encountered or catheter stretches, stop.Continued pulling could break the catheter.It¿s advisable to cover the site with warm compresses, and wait 30 to 60 minutes, and try again.The patient¿s body movements may relieve the catheter to allow easier removal.Do not cut or forcefully remove catheter.As previously reported, the review of the device history record found that the lot met the process specifications, including the quality control acceptance criteria prior to release.An historical review indicated that no other complaints were reported for this reported incident and related to the same model number.A technical bulletin (mk-00021), tips for preventing in-situ catheter breakage, was sent to the customer.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

Event Description

Additional information was received on 06/03/2015.The incident was described as, "part of a catheter had to be retrieved from a patient following it breaking off on removal." the incident happened at the hospital.

• Brand Name: ON-Q PAIN RELIEF SYSTEM SILVERSOAKER 5IN(12.5CM): 270 ML, 4ML/HR (2+2 DUAL SITE)
• Type of Device: ELASTOMERIC PUMP
• 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
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4788610
• MDR Text Key: 5880332
• Report Number: 2026095-2015-00157
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2015

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: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: PS12505-A
• Device Catalogue Number: 101362100
• Device Lot Number: 0201196017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2015
• Initial Date FDA Received: 05/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/19/2015; 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2013
• 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
• Treatment: LEVOBUPIVACAINE 675MG