MAUDE Adverse Event Report: COVIDIEN 18G BLUNTFILL W/FILTER; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number 11811022F

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information was requested but at this time no additional details have been provided.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer states: needle broke off luerlock when nurse went to remove it.

Manufacturer Narrative

Submit date: 11-mar-2019.Section e1 was updated with the facility and address based off additional information received on 11-mar-2019.Section h6 - patient code was also updated from no consequences or impact to patient to no patient involvement based off additional information received on 11-mar-2019.

• Brand Name: 18G BLUNTFILL W/FILTER
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 8405906
• MDR Text Key: 138355092
• Report Number: 1282497-2019-08313
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 11811022F
• Device Catalogue Number: 11811022F
• Device Lot Number: 18070401
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 03/01/2019
• Supplement Dates FDA Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1