MAUDE Adverse Event Report: HALYARD ON-Q CATHETER

Device Problems Break (1069); Device, or device fragments remain in patient (1527); Tip breakage (1638)

Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); Device Embedded In Tissue or Plaque (3165)

Event Date 12/11/2014

Event Type  Injury  

Event Description

Procedure: thoracotomy with left upper lobectomy.Cathplace: left anterior chest.It was reported that a catheter broke under a patient's skin.It was reported as, "according to staff, patient was receiving pain management therapy via an on-q pain ball with catheter in the left lateral back and left anterior chest sites.During assessment of patient, rn noted that the left anterior catheter was broken.Notified pa who removed subcutaneous catheter, observed small piece of catheter was left under the skin.Physician and on-q pain rep notified".It was reported that the device is available for return and analysis.Additional info was requested, however, is not available at this time.

Manufacturer Narrative

Method: the device was reported to be returning for an evaluation and at this time is pending return.The lot number provided 0200989916 belongs to an on-q pump which does not include a catheter, therefore for the lot number and model number are unk at this time.Results: at this time the investigation is still in progress.Once the device is received, testing will be performed and results will be provided once completed.Conclusions: once the investigation and device analysis are completed a f/u report will be submitted.A copy of the medwatch form number 18004-199-2014-0006 is attached.Info from this incident has been included in our product complaint and mdr trend reporting systems.Trend info is used to identify the need for additional investigations.

• Brand Name: ON-Q CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): HALYARD; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4418684
• MDR Text Key: 5378906
• Report Number: 2026095-2014-00303
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/16/2014,12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/12/2014
• Event Location: Other
• Date Report to Manufacturer: 12/17/2014
• Date Manufacturer Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: No
• 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: DRUG: UNK- ASKED NOT PROVIDED,; P400X4D PUMP,
• Patient Age: 74 YR
• Patient Weight: 40