MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SURETRANS A/T; AUTOTRANSFUSION SYSTEM

Catalog Number 8594000

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

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.Functional evaluation of the complaint sample identified a puncture/ hole on the clear sidewall of the solcovac 3-spring evacuator causing irregular rate of aspiration in the device.At this point is unclear how or what caused the puncture to the clear sidewall, root cause cannot be determined at this time.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

It was reported to davol (b)(4), that during testing at davol, when the spring evacuator was compressed, the device appeared to be aspirating slower than what is specified.The issue was resolved by isolating the 3-spring evacuator, compressing it three times and sealing it.Based on the observation of the qe, a leak exists in the 3-spring evacuator.The packaging appeared to be fine, and nothing out of the ordinary was observed while opening the device.

• Brand Name: SURETRANS A/T
• Type of Device: AUTOTRANSFUSION SYSTEM
• 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: 6726409
• MDR Text Key: 80706837
• Report Number: 1213643-2017-00416
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• PMA/PMN Number: K913247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/19/2017

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: Other
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 8594000
• Device Lot Number: JUZAF530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2015
• Initial Date FDA Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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