MAUDE Adverse Event Report: JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO MEDICAL ACTION INDUSTRIES; LAPAROTOMY SPONGE

Model Number B250

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2018

Event Type  Injury  

Event Description

Avid medical is the manufacturer of a custom procedure tray, vast024/lot#1219829, which includes the following component: sponge, lap 18x18 pw 5s loops, vendor part # b250/ lot # 1606jk326c manufactured by (b)(4) province jianerkang.Avid medical received a complaint on (b)(4) 2018 originated by (b)(6), rn, cnor /assistant nurse manager of (b)(6) medical center.The complaint alleges white particulates were noticed on a patient's heart when the sponge was removed from chest during procedure.These particulates were removed using forceps and a thorough search was conducted of the patient's pericardium, but no more additional particulates were discovered.The affected lap sponge was contaminated therefore the product was not available for evaluation; however, photos were provided.Avid medical issued formal complaint # (b)(4) to the manufacturer (b)(4) province jianerkang concerning the lap sponge debris for further investigation and corrective action implementation.

• Brand Name: MEDICAL ACTION INDUSTRIES
• Type of Device: LAPAROTOMY SPONGE
• Manufacturer (Section D): JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO; no. 1 jianerkang road; zhixi town, jintan city; jiangsu jiangsu
• Manufacturer (Section G): AVID MEDICAL INC., AN OWENS AND MINOR COMPANY; 9000 westmont drive; toano VA 23168
• Manufacturer Contact: nichole early ; 9000 westmont drive; toano, VA 23168 ; 7575663510
• MDR Report Key: 8030246
• MDR Text Key: 125903782
• Report Number: 1047429-2018-00010
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 50809160000029
• UDI-Public: 50809160000029
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B250
• Device Catalogue Number: B250
• Device Lot Number: 1606JK326C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2018
• 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