MAUDE Adverse Event Report: AMSINO MEDICAL CO., LTD. RECEPTAL CANNISTER KG 1600 CCE (10/CS); 80GCX

Catalog Number 43423

Device Problem Suction Problem (2170)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

The customer contact reported no suction.The device was to be used to suction unspecified fluids during an unspecified procedure.During testing of the device prior to patient use, it was reported that no vacuum could be established with 5 or 6 different liners.It was reported that the lids of the liners did not fit properly onto the cannister, were loose, and easily cam off the canister and little vacuum was established.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.The lot number of the device that was in use it unknown.The customer contact identified two possible lot number (plots).The possible lot numbers are 31004 and 31002.The international affiliate was contacted and information on reprocessing of the device was requested.No response has been received.This report represents all information known by the reported upon query by hospira personnel.

• Brand Name: RECEPTAL CANNISTER KG 1600 CCE (10/CS)
• Type of Device: 80GCX
• Manufacturer (Section D): AMSINO MEDICAL CO., LTD.; shanghai 2016 13; CH 201613
• Manufacturer (Section G): AMSINO MEDICAL CO., LTD.; shanghai ; CH
• Manufacturer Contact: juergen schmider, md, vp ; 275 n. field dr.; bldg. no. h2-1east, dept no. 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 3891438
• MDR Text Key: 4650048
• Report Number: 3005515211-2014-00016
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 43423
• Device Lot Number: PLOTSKY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SUCTION PUMP: MEGAMED 700, MFR UNK; RECEPTAL LINERS: LN OG904, LOT# 35200