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

Model Number 412012

Device Problems Device Contaminated During Manufacture or Shipping (2969); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2017

Event Type  malfunction  

Event Description

Braun mini-spike dispensing pin was received sealed in the individual package with multiple dark brown droplets on the plastic cover surrounding the spike.

• Brand Name: MINI-SPIKE®
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 6954528
• MDR Text Key: 89486297
• Report Number: 6954528
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2022
• Device Model Number: 412012
• Device Catalogue Number: 412012
• Device Lot Number: 0061557449
• Other Device ID Number: NDC / WSN NUMBER 08021-4120-1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2017
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2017
• Type of Device Usage: N
• Patient Sequence Number: 1