MAUDE Adverse Event Report: COVIDIEN FISHER 1 GA SHARPS CONT - RED; CONTAINER, SHARPS

Model Number 31157111

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

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 reported that they autoclaved a fisherbrand sharps bin and needles pierced the bin at some point during the autoclave cycle.The conditions of the autoclave cycle were 132c for 60 minutes.

• Brand Name: FISHER 1 GA SHARPS CONT - RED
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer (Section G): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11556903
• MDR Text Key: 241939583
• Report Number: 1424643-2021-00592
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00613647001394
• UDI-Public: 00613647001394
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 31157111
• Device Catalogue Number: 31157111
• Device Lot Number: 20J11563
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1