MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PACK C-SECTION-KENNESTONE

Catalog Number WK210B

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that during an emergency c-section, a blade detached from a handle and fell into the surgical site, requiring an additional procedure in order to retrieve.The blade detached from the handle during the procedure and reportedly fell onto the surgical field.It was determined to be "ok" per the staff present during the procedure.After delivery, the staff "noticed the blade was not there." a c-arm x-ray was performed which showed the blade "was inside the bladder appearing to be floating." a urologist was called in to perform an emergency extraction of the blade.The blade involved in this incident was reportedly discarded and was not returned to the manufacturer for evaluation.Information regarding the handle used during this incident is unknown.No other patient, procedural, or product information was reported to the manufacturer.Due to the need for additional surgical intervention in order to retrieved the blade, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that during an emergency c-section, a blade detached from a handle and fell into the surgical site, requiring an additional procedure in order to retrieve.

• Type of Device: PACK C-SECTION-KENNESTONE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093 ; 2249311458
• MDR Report Key: 7326881
• MDR Text Key: 101987590
• Report Number: 1423395-2018-00011
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2018

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?: No
• Device Operator: Physician
• Device Catalogue Number: WK210B
• Device Lot Number: 17LB1064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: 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