MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PROTECTIV; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number 3066

Device Problem Material Integrity Problem (2978)

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

Event Date 05/25/2017

Event Type  malfunction  

Event Description

Several members of our clinical staff noticed that the product appeared to be faulty.The product was curling before insertion, and could not be used.Supply chain staff removed a specific lot number that appeared to be at issue.It is unclear whether more lots with this issue.No known patient harm to date.

• Brand Name: PROTECTIV
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 201 west queen st.; southington CT 06489
• MDR Report Key: 6837958
• MDR Text Key: 84401865
• Report Number: 6837958
• Device Sequence Number: 1
• Product Code: FOZ
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 3066
• Device Lot Number: 3403029
• Other Device ID Number: 20G 1-1/4IN (PINK)
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1