MAUDE Adverse Event Report: COV LP/LLC, CRYSTAL LAKE, MFG SHARPSAFETY; CONTAINER, SHARPS

Model Number 89651

Device Problem Inadequate Storage (1600)

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

Event Date 07/05/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports product lid was malformed and it came off from the body easily.No patient harm.

Manufacturer Narrative

The sample received consisted of the lid only.The lid and cowl component were received without the welding operation.As from sample evaluation it was observed that the lid assembly step was missed during manufacturing operation.The reported condition was observed during the sample evaluation.A device history record (dhr) was not reviewed as no lot number could be provided.A probable root cause has been determined to be human error and failure to follow the lid assembly welding operation step during manufacturing before packaging lids into the case.The standard work for assembly and inspection procedure were reviewed and found to be adequate for the manufacturing process.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 as unassembled lid should not be used.There is no known impact or consequence to patient or end user safety.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports product lid was malformed and it came off from the body easily.No patient harm.

• Brand Name: SHARPSAFETY
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COV LP/LLC, CRYSTAL LAKE, MFG; 815 tek dr; crystal lake IL 60014 8172
• Manufacturer (Section G): COV LP/LLC, CRYSTAL LAKE, MFG; 815 tek dr; crystal lake IL 60014 8172
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6762011
• MDR Text Key: 81673564
• Report Number: 1424643-2017-05015
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89651
• Device Catalogue Number: 89651
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1