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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC CMPJ CUSTOM PACK - ADD ON-EASTON SPINE PACK CUSTOM SURGICAL PACK

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MEDLINE INDUSTRIES, INC CMPJ CUSTOM PACK - ADD ON-EASTON SPINE PACK CUSTOM SURGICAL PACK Back to Search Results
Catalog Number CMPJ08233
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/01/2018
Event Type  Malfunction  
Event Description

A medline pack was found to have a large piece of dirty tape. The room was torn down and another set up was obtained. No harm came to the patient and the procedure was completed as planned. Manufacturer response for custom surgical pack, cmpj custom pack - add on-(b)(4) spine pack (per site reporter). Medline is investigating contaminated custom packs. Any further information received will be shared with medsun as it becomes available.

 
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Brand NameCMPJ CUSTOM PACK - ADD ON-EASTON SPINE PACK
Type of DeviceCUSTOM SURGICAL PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC
1 medline place
mundelein IL 60060
MDR Report Key7285314
MDR Text Key100643305
Report Number7285314
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/21/2018
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date01/31/2019
Device Catalogue NumberCMPJ08233
Device LOT Number17ED2771
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/02/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/12/2018
Device Age1 dy
Event Location Hospital
Date Report TO Manufacturer02/12/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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