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

Catalog Number 8594000

Device Problems Disconnection (1171); Difficult to Open or Close (2921)

Patient Problems Exposure to Body Fluids (1745); No Consequences Or Impact To Patient (2199)

Event Date 10/17/2016

Event Type  Injury  

Manufacturer Narrative

The subject product was not returned for evaluation.A product lot number was requested but was not made available by the customer, therefore, a review of the manufacturing records could not be conducted.As the sample was not returned for evaluation no definitive conclusions can be made at this time.It is possible that the user did not engage the pinch clamp, or did not close the pinch clamp before opening the luer-lock.The pinch clamp is of a robust design and should not open spontaneously or through inadvertent contact.A review of complaint records for the past 24-months found no similar complaints have been reported to davol.The ifu for the suretrans autotransfusion system provides detailed instructions on the proper set up of the device, transferring of blood, and reinfusion of blood.Not available for return.

Event Description

The following was reported to davol by the customer contact: it is alleged that a member of the nursing staff was exposed to the patient's blood while using the suretrans autotransfusion device.The customer stated that the pinch clamps on the suretrans device are hard to close and require two hands to secure.The contact alleged that the pinch clamp opened unexpectedly when the user opened the systems luer-lock quick disconnect and the blood splashed into the nurses face and mouth, and the nurse was treated for exposure.The event was reported to their risk management department.Davol requested the sample be returned for evaluation but was informed that it had been discarded.Contact confirmed that there was no adverse patient outcome as a result of the event.The contact reports that the nurse was wearing eye protection at the time, but not a mask or face shield.

Manufacturer Narrative

This follow-up mdr is being submitted as a result of a retrospective review of davol's mdr files.

• 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: 6106568
• MDR Text Key: 60029551
• Report Number: 1213643-2016-00526
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8594000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/31/2017
• 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 Outcome(s): Required Intervention