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

Catalog Number UNKAA074

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Inconclusive complaint.It was reported that the suretrans device was disconnecting the y connector.Information regarding if any additional cuts/alterations to the y connector and drain size were being made remains unknown.The device remained in use with no patient injury.The subject product was not returned for evaluation.With out a sample or any additional info, no disconnect can be made between the reported event and the davol product in question.If additional information is obtained or if the sample is returned, this report will be updated.(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.Device never returned.

Event Description

Per customer contact: alleged the suretrans device was disconnecting at the y connector.Contact is not sure if the staff had made any additional cuts/alterations to the y connector prior to connection to the suretrans.Information was limited.As reported they were able to work around this problem and the device remains in use and there was no patient injury that presented.

• 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: 6743548
• MDR Text Key: 81145991
• Report Number: 1213643-2017-00453
• 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: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2016
• 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