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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PASSING TRAY FROM TRINITY C-SEC W/LINEN CDS

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MEDLINE INDUSTRIES INC.; PASSING TRAY FROM TRINITY C-SEC W/LINEN CDS Back to Search Results
Catalog Number DYNJ905269B
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/01/2019
Event Type  malfunction  
Manufacturer Narrative
It was reported that the yellow passing tray (from custom the c-section pack) was received with a crack and missing pieces.Reportedly, a plastic piece went into the patient's abdomen.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.It is unknown how the broken piece from the yellow passing tray reached the surgical site and how the broken piece was removed from the surgical site.Due to the reported event, this medwatch is being filed.A sample was returned for evaluation and the complaint was confirmed.The placement of the yellow passing tray was reviewed in the picture production placement form of this custom c-section pack.A definitive root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
 
Event Description
It was reported that a plastic piece from the yellow passing tray went into the patient's abdomen.
 
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Type of Device
PASSING TRAY FROM TRINITY C-SEC W/LINEN CDS
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
bermon punzalan
three lakes drive
northfield, IL 60093
MDR Report Key8407953
MDR Text Key138567963
Report Number1423395-2019-00008
Device Sequence Number1
Product Code OHM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDYNJ905269B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2019
Initial Date Manufacturer Received 02/11/2019
Initial Date FDA Received03/11/2019
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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