MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE HAND PACK (HPPSE)258; GENERAL SURGERY TRAY (KIT)

Model Number SOP21HPPSF

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/1980

Event Type  Injury  

Manufacturer Narrative

On the date 04/07/19, for work order (b)(4), production team 201 produced a total of 135 kits and performed 10 kit inspections with no defects found.A quality assurance inspection was also performed on the order with no defects found.There were no reports of any deviations or non -conformance investigations (nci) generated for the work order.The lot number of component 4m2624h4 was 1446961.There was no special instruction on the affected component.There were no reports for any scrap, return to stock (rts) or additional pick generated for component 4m2624h4 a physical sample was not available at the time of the complaint investigation.Only a sample photo was used during the sample review process.The image query, electronic device history record (edhr), and bill of materials (bom) were all reviewed for component placement and material usage for work order (b)(4).The work orders bill of materials consisted of 31 components of which ¿1 kit was reported for a powder like substance on the outer wrap¿.Per procedure all personnel areas are required to have head covers, bouffant, and beard covers ( if applicable) worn in all production and manufacturing areas.Sample picture was available and it looks like a powder substance was in outer wrap.The production team did not notice any contamination of this sort during the assembly process.The contamination could have come from vendor or the assemblers themselves; however, the root cause of the contamination is unknown at this time.We have talked to the personnel involved in this failure to maintain procedures in place to prevent and reduce any type of contamination working with assembly process and suppliers, the production staff were notified to reinforce and follow the cleaning protocol and review the components to prevent and detect any type of contamination during the assembly process, and thus avoid and prevent any type of contamination.

Event Description

Customer informed cardinal health that they have had an incident of an internal hand infection.This case used a cardinal health hand pack sop21hppsf where a film-like, tacky and grimy substance was present on the outside of the sterilization pouch and transferred to the staff¿s hands.Customer stated they have not conclusively ruled out that the infection had indeed come from the hand packs.The event date was unknown.Customer would not provide demographics or clinical data after multiple attempts.Although no injury was reported, cardinal health is filing a report for this incident.

• Brand Name: HAND PACK (HPPSE)258
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 9729605
• MDR Text Key: 192649896
• Report Number: 1423537-2020-00421
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10888439440010
• UDI-Public: 10888439440010
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SOP21HPPSF
• Device Catalogue Number: SOP21HPPSF
• Device Lot Number: 225083
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2020
• Date Device Manufactured: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other