MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SURETRANS; AUTOTRANSFUSION APPARATUS

Catalog Number UNKAA074

Device Problems Disconnection (1171); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2015

Event Type  malfunction  

Manufacturer Narrative

This initial mdr is being submitted as a result of a retrospective review of davol¿s mdr decisions and the initial decision not to report the event is being revised to reflect updated company procedures.The root cause of the reported issue has been determined to be user related.The universal y-connector with a 1/8¿ drain tube attached was returned for evaluation.The 1/8¿ drain tube on the returned sample was easily removed from the y-connector.The outside diameter of the returned 1/8¿ drain was measured and confirmed to be with specification.A visual examination of the returned y-connector confirmed that the user facility had cut the y-connector leg where the 1/8¿ drain had been inserted.The ifu for the suretrans device states "using aseptic technique, cut the universal y-connector located at the end of the patient drainage tube to the appropriate wound drain size (one leg of the y-connector is pre-cut for 1/8 inch drain.).¿ the cutting of the y-connector is only required to accommodate the insertion of drains larger than 1/8¿.Therefore, since the user facility is using a 1/8¿ drain tube, the y connector should be used as supplied.The reported disconnection of the 1/8¿ drain tube is due the user facility cutting the y-connector.The information provided by bard 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 bard.

Event Description

Per customer contact: alleged the suretrans device tubing came disconnected at the y connector site during use.The device was not full and there was no pulling or tension on the tubing.Upon set up the y connector is being cut straight across.The device was placed during spine surgery and was in use 4 hours prior to the disconnection.The device remained in use and tape was applied to secure the attachment.No patient injury.

• Brand Name: SURETRANS
• Type of Device: AUTOTRANSFUSION APPARATUS
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 6741195
• MDR Text Key: 80953822
• Report Number: 1213643-2017-00438
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 46 YR