MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PUMP SILVERSOAKER 2.5IN (6.5CM): 100ML, 2ML/HR; ELASTOMERIC PUMP

Model Number PM012-A

Device Problems Cut In Material (2454); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/28/2015

Event Type  malfunction  

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.

Event Description

Procedure: right big toe fusion ((b)(6) 2015).Cathplace: approximately the middle leg.It was reported that a patient cut a catheter at the end of an infusion with a pump, as the patient felt uneasy about pulling it out correctly.The remaining cut portion of the catheter retained in the patient was approximately 8 inches long.The patient reported that the catheter was located under the cast and that the patient wanted to wait until the appointment with the physician to have it removed with the cast on her leg.The patient later reported that the anesthesiologist informed the patient that it was alright to wait for the appointment or the patient could try to pull the catheter out.The patient stated that now the patient could see where the catheter was inserted and so decided to remove the catheter; once it was removed it was confirmed that the end of the catheter, the black tip, was observed.The patient was reported as doing well.Additional information was received on 07/29/2015.The previous day, the patient read the instructions for removal of the catheter.When the patient pulled the catheter, the patient met a little resistance.Furthermore, since the patient could not see the location of the catheter insertion, as it was inside the cast, the patient decided to cut it instead.The sample is available for return.

Manufacturer Narrative

Method: the actual device was received and investigated.A visual and microscopic inspection was performed, in addition to photographic images taken.Results: the visual inspection found that one silver-soaker catheter was received in two pieces.The silver-soaker catheter was examined under a microscope magnified at 2x.The catheters edges indicates that a sharp object was used.Conclusion: the investigation summary concludes that the silver-soaker catheter was received not fully intact and in two pieces.The edges indicate that a sharp object was used to cut/shear the catheter in two.It was reported that upon removal the patient met a little resistance when pulling and could not see the location of the catheter as a portion was inside a cast, therefore the patient decided to cut it instead.The root cause was determined to be the user.Based on this investigation, the complaint is confirmed.Based on the device history record review for the reported lot number the device met all specifications at release.Information from this incident has been included in our product complaint trend reporting systems for monitoring, tracking and trending.

• Brand Name: ON-Q PUMP SILVERSOAKER 2.5IN (6.5CM): 100ML, 2ML/HR
• 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.
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5022783
• MDR Text Key: 24687892
• Report Number: 2026095-2015-00219
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Followup
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PM012-A
• Device Catalogue Number: 101370100
• Device Lot Number: 0202141388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 57