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

Model Number	8970Y
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently under way; upon completion the results will be forwarded.
Event or Problem Description
The customer states the bottom of the sharps container broke when the nurse was preparing to remove the container.Bottom broke out and contents spilled out, clients in room nurse moved them out of the room so that there was no danger to them.Container contained dirty sharps so disposed of as per regular process.
Additional Manufacturer Narrative
The reported condition cannot be observed as there were no photos or physical samples provided for a sample evaluation.The device history records (dhr) data was reviewed for and an internal non conformance report (ncr) issued for missing inserts into containers as per standard work order.The issue was identified at start up and all affected product was contained as part of the ncr.The product was reworked and inspected per specified acceptable quality levels (aql) and passed the aql inspection.The most probable root cause is human error; failure to add insert prior to sealing the case and as ncr rework is inspected per aql.Also outside of the medtronic facility, another distribution center may have repackaged the product.Medtronic has case quantity shipped (b)(4) each per case for product code (b)(4).As per the complaint the number of defective quantity is 1 each, which indicates that the case may have bee n broken down to a smaller shipping quantity by a distribution center to the end user.Also there is no evidence documented in the complaint about whether or not the container is inspected for any damage prior to use.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.The product should be inspected prior to use for any damage.Also there is no information about if customer received full case or only one each for use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states the bottom of the sharps container broke when the nurse was preparing to remove the container.Bottom broke out and contents spilled out, clients in room nurse moved them out of the room so that there was no danger to them.Container contained dirty sharps so disposed of as per regular process.

• Brand Name: SHARPSAFETY
• Manufacturer (Section D): COV LP/LLC, CRYSTAL LAKE, MFG; 815 tek dr; crystal lake IL 60014 8172
• MDR Report Key: 6435726
• Report Number: 1424643-2017-05003
• Device Sequence Number: 1042149
• Product Code: MMK
• UDI-Device Identifier: 20884521018386
• UDI-Public: 20884521018386
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2017

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
• Operator of Device: Health Professional
• Device Model Number: 8970Y
• Device Catalogue Number: 8970Y
• Device Lot Number: 00172667
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/27/2017
• Supplement Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1