MAUDE Adverse Event Report: CONOD MEDICAL CO., LIMITED MEDLINE SILICONE BULB EVACUATOR - JP DRAIN; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number DYNJWE1305

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/21/2019

Event Type  Injury  

Event Description

Jp drain placed during acute surgical intervention.Drain did not effectively work as there was residual bleeding in the drainage tube but not in the collection chamber.Build up of recurrent bleeding required another surgical intervention the following day.

• Brand Name: MEDLINE SILICONE BULB EVACUATOR - JP DRAIN
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): CONOD MEDICAL CO., LIMITED; no. 38 hongfeng road; baimao guli town ; CH
• MDR Report Key: 8857053
• MDR Text Key: 153404162
• Report Number: MW5088695
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2021
• Device Model Number: DYNJWE1305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 82