MAUDE Adverse Event Report: CODMAN AND SHURTEFF, INC. TRUFILL BCA

Model Number 631100001

Device Problems Break (1069); Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2018

Event Type  Injury  

Event Description

Trufill nvca plastic puncture cap not sharp enough to puncture tube.Container broke trying to get the top to puncture.

• Brand Name: TRUFILL BCA
• Type of Device: BCA
• Manufacturer (Section D): CODMAN AND SHURTEFF, INC.
• MDR Report Key: 7421060
• MDR Text Key: 105267829
• Report Number: MW5076412
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 631100001
• Device Lot Number: HM2554
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR