MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SAMPLING SYSTEM; BLOOD SAMPLING SYSTEM,

Model Number 682000

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that the connection between a high pressure 3-way stopcock and a pt tube got loosened on its own during procedure, the customer alleges that the connection had to be tightened repeatedly.

Manufacturer Narrative

The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to rough handling during use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

• Brand Name: SAFEDRAW BLOOD SAMPLING SYSTEM
• Type of Device: BLOOD SAMPLING SYSTEM,
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, sgp 76892 6; SN 768926
• MDR Report Key: 10309717
• MDR Text Key: 201907805
• Report Number: 8020616-2020-00038
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 00886333620005
• UDI-Public: 00886333620005
• Combination Product (y/n): N
• PMA/PMN Number: K885235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 682000
• Device Catalogue Number: 689476/JPA
• Device Lot Number: C1361358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 07/28/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1