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

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.

• 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 Key: 8407953
• MDR Text Key: 138567963
• Report Number: 1423395-2019-00008
• Device Sequence Number: 1
• Product Code: OHM
• 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,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 Number: DYNJ905269B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention