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

Model Number	B250
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: LAPAROTOMY SPONGE
• Manufacturer (Section D): JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO; no. 1 jianerkang road; zhixi town, jintan city; jiangsu jiangsu
• MDR Report Key: 8030246
• Report Number: 1047429-2018-00010
• Device Sequence Number: 13811932
• Product Code: GDY
• UDI-Device Identifier: 50809160000029
• UDI-Public: 50809160000029
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: B250
• Device Catalogue Number: B250
• Device Lot Number: 1606JK326C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention