MAUDE Adverse Event Report: BAXTER HEALTHCARE ACCESS; SET, BLOOD TRANSFUSION

Catalog Number 4C8723

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a nurse experienced tendonitis in the hand coincident with spiking iv (intravenous) bags with clearlink system y-type blood/solution sets.It was reported that the "very short spike on the set makes it hard to spike the iv bag" and further described as "it takes a lot of strength to get through the bag".The sets are used regularly in the anesthesia department.It was reported that recently the hospital has begun starting all of the iv's for surgery up on the acu (ambulatory care unit); so now they are spiking multiple bags a day (unspecified number).Subsequently, on an unreported date, a nurse developed tendonitis in the right hand.Due to the event, the nurse is currently out (b)(6) for six to eight weeks (dates not reported).Unspecified treatment was rendered, however, not reported.Further outcome for the event was not reported.No additional information is available.

• Brand Name: ACCESS
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago ; CS
• Manufacturer (Section G): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago ; CS
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5088318
• MDR Text Key: 26186862
• Report Number: 1416980-2015-36526
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 09/18/2015

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
• Device Operator: Nurse
• Device Catalogue Number: 4C8723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: IV SOLUTION BAGS (UNSPECIFIED)
• Patient Outcome(s): Required Intervention