FDA Adverse Event Malfunction Summary report: N

CARDINAL HEALTH

MDR report key: 14873718 · Received June 30, 2022

Report

Report Number: 14873718
Event Type: Malfunction
Date Received: June 30, 2022
Date of Event: May 24, 2022
Report Date: June 22, 2022
Manufacturer: CARDINAL HEALTH 200, LLC
Product Code: LRO
Product Problem: Yes
Report Source: User Facility report
Reporter Location: CT
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Description of Event or Problem · 0

UPON OPENING FOR A CASE AND PERFORMING A FIRST COUNT, THE SURGICAL TECHNICIAN NOTICES A SUTURE BOOT RACK WITH ONLY 9 SUTURE BOOTS. AFTER EXTENSIBILITY LOOKING AT THE BACK TABLE AND BEING UNABLE TO LOCATE THE SUTURE BOOT, IT WAS DETERMINED THAT THE SUTURE BOOT MUST HAVE BEEN MISSING FROM THE PACK BECAUSE IT DID NOT HAVE AN INDENTATION IN THE HOLDER LIKE THE REST OF THE SB DID. THE PACK WAS REMOVED AND REPLACED WITHOUT DELAY. MANUFACTURER RESPONSE FOR SUTURE BOOT PACK, SUTURE BOOTS TRANSPLANT PACK (PER SITE REPORTER) OR MANAGER ESCALATED IT IMMEDIATELY TO THE REPRESENTATIVE.

Description of Event or Problem · 0

UPON OPENING FOR A CASE AND PERFORMING A FIRST COUNT, THE SURGICAL TECHNICIAN NOTICES A SUTURE BOOT RACK WITH ONLY 9 SUTURE BOOTS. AFTER EXTENSIBILITY LOOKING AT THE BACK TABLE AND BEING UNABLE TO LOCATE THE SUTURE BOOT, IT WAS DETERMINED THAT THE SUTURE BOOT MUST HAVE BEEN MISSING FROM THE PACK BECAUSE IT DID NOT HAVE AN INDENTATION IN THE HOLDER LIKE THE REST OF THE SB DID. THE PACK WAS REMOVED AND REPLACED WITHOUT DELAY. MANUFACTURER RESPONSE FOR SUTURE BOOT PACK, SUTURE BOOTS TRANSPLANT PACK (PER SITE REPORTER). OR MANAGER ESCALATED IT IMMEDIATELY TO THE REPRESENTATIVE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
944498	CARDINAL HEALTH	GENERAL SURGERY TRAY	LRO	CARDINAL HEALTH 200, LLC	SBA7CTPY11

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Other