MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. BLOOD COLLECTION ADAPTER; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 220320

Device Problems Break (1069); Flushing Problem (1252); Free or Unrestricted Flow (2945)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/29/2022

Event Type  malfunction  

Event Description

Rn (registered nurse) was using blood collection adapter to draw blood specimens from patient's peripheral iv line.When the blood collection adapter was disconnected from the blue clave neutral connector, blood continued to drip from the peripheral iv.Rn was unable to stop blood flow through blue clave neutral connector and unable to flush the line with saline.Rn perceived that a small piece of plastic from the blood collection adapter had broken off and remain engaged in the clave neutral connector.The rn changed the clave neutral connector and was then able to flush the iv line with saline.The new clave neutral connector also controlled the flow of blood from the iv.

• Brand Name: BLOOD COLLECTION ADAPTER
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15248788
• MDR Text Key: 298139600
• Report Number: 15248788
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 220320
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12410 DA
• Patient Sex: Female
• Patient Weight: 82 KG