MAUDE Adverse Event Report: COVIDIEN SHARPSAFETY; STAND, INFUSION

Model Number 8940FP

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4): the sample was received and reported condition was observed.Also video was evaluated for sample evaluation.The lid open-close mechanism was working as foot pedal release.From the sample evaluation it seems like cart sidewall body was warped in which may cause external pressure on the container during use for lid open-close function.

Event Description

Per video: lid fails to open automatically, needs to be done manually.

Manufacturer Narrative

The sample was received and the reported condition was observed.Also a video was submitted for evaluation.The lid open-close mechanism was working as foot pedal release.From the sample evaluation it seems like cart sidewall body was warped in which may cause external pressure on the container during use for lid open-close function.A device history record was not reviewed as lot number was unknown.A possible root cause may be attributed to the cart being damaged during the shipping and handling process which could cause the cart sidewall to warp inwards resulting in resistance to the lid function.Also the reported condition could occur if there was a variation in the manufacturing process due to manual assembly of the cart.Based on the existing controls, the internal reject and the complaint history review, no formal investigation is required at this time.This will be used for tracking and trending purposes.This issue has been determined to be an isolated event with minimal risk as non-functional cart should not be used and replaced.If information is provided in the future, a supplemental report will be issued.

Event Description

Per video: lid fails to open automatically, needs to be done manually.

• Brand Name: SHARPSAFETY
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL
• Manufacturer (Section G): COV LP/LLC, CRYSTAL LAKE, MFG; 815 tek dr; crystal lake IL 60014 8172
• Manufacturer Contact: edward almieda ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6666072
• MDR Text Key: 78520102
• Report Number: 1219103-2017-05007
• Device Sequence Number: 0
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8940FP
• Device Catalogue Number: 8940FP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1