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

Catalog Number 8592000

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

Photos of the subject product were provided by the customer.The photos depict the blood transfer bag with visible blood inside and what appears to be a drop of blood leaking out of the transfer bag in the area of the transfer tube.A review of the manufacturing records for the reported production lot revealed that there were no discrepancies during manufacture and there was no evidence of any manufacturing related issue which would cause or contribute to the reported event.Based on the information available at this time, no definitive conclusions can be made.The information provided by bard represents all of the known information at this time.

Event Description

Information as reported by the user facility: it was reported that following placement of the suretrans device in surgery, the patient's blood was collected and upon attempting to re-infuse back into the patient, a hole in the collection bag was noted.This hole was not at a connection site and was noted to be at the bottom of the blood collection bag.There was no injury to the patient as the hole was noted prior to the transfusion process.Use of the suretrans device was discontinued, the blood was not re-infused, and a new device was set up.

• Brand Name: SURETRANS
• Type of Device: APPARATUS, AUTOTRANSFUSION
• 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: anna smith ; 100 crossings blvd.; warwick, RI 02886 ; 4018258449
• MDR Report Key: 5702751
• MDR Text Key: 46671645
• Report Number: 1213643-2016-00244
• 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: 05/13/2016

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: 02/28/2021
• Device Catalogue Number: 8592000
• Device Lot Number: JUAQF257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/13/2016
• Initial Date FDA Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2016
• 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