MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SIMPULSE SOLO; PULSED LAVAGE SUCTION AND IRRIGATION

Catalog Number 0067590

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

The subject product has been received and an evaluation has been performed.The sample evaluation found battery corrosion has leached from the handle inside the package.The battery compartment was deformed as was the locking tabs on the battery compartment.The batteries were observed to be heavily corroded with tears in the battery labels and a gap/breach was detected on the positive ends of two of the four batteries.An impact dent was also detected on the blister tray of the sterile package.Based on the physical condition of the device and damage noted on the tray, it appears that the problem most likely was caused by transit damage or a handling issue.The information provided by bard represents all of the known information at this time.

Event Description

Information as provided by the contact: (b)(6) 2015: staff nurse observed water leakage from simpulse solo system during the surgery before the package was opened.The product remains in the original sterile pack.The device was not used on the patient.Another simpulse solo was opened for use in the same case.

• Brand Name: SIMPULSE SOLO
• Type of Device: PULSED LAVAGE SUCTION AND IRRIGATION
• 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: 5100720
• MDR Text Key: 26639458
• Report Number: 1213643-2015-00329
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: K942886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 0067590
• Device Lot Number: JUYGF290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2014
• 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