MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. MINI SPIKE DISP PIN; SET, I.V. FLUID TRANSFER

Catalog Number DP1800SC

Device Problem Air/Gas in Device (4062)

Patient Problems Pain (1994); Shaking/Tremors (2515)

Event Date 10/28/2021

Event Type  Injury  

Event Description

Spontaneous call from patient called pharmacy while she was doing her cartridge change.Patient reported that her hands were shaking due to site pain.She didn't have anyone that can help with cartridge change at the moment so she spilled about 2/3 of her new remodulin bottle due to spike issue.Patient also wasted one cartridge because she couldn't get the bubbles out.Reported to (b)(6) by pt/caregiver.

• Brand Name: MINI SPIKE DISP PIN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 12745337
• MDR Text Key: 280198469
• Report Number: MW5105110
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DP1800SC
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR