MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE GENERAL SURGERY PACK (DSDCB)468; GENERAL SURGERY TRAY (KIT)

Model Number SBAC2DSDCC

Device Problem Nonstandard Device (1420)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Sepsis (2067); Fluid Discharge (2686)

Event Date 12/15/1979

Event Type  Injury  

Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.

Event Description

Customer informed cardinal health that they have noticed an increase in infections and believes it¿s in conjunction with the gown recall.Patient had a left hip hemi-arthroplasty on (b)(6) 2019.On (b)(6) 2019 persistent drainage.On (b)(6) 2019 persistent drainage.On (b)(6) 2020 persistent drainage, and elevated esr, crp, and white blood count.On (b)(6) 2020 patient diagnosed with sepsis due to infected hematoma, patient with + troponins immediately post-op.On (b)(6) 2020 irrigation and debridement of postsurgical wound including evacuation of hematoma.On (b)(6) 2020 patient started on vancomycin, cefepime, and levaquin while inpatient.On (b)(6) 2020 patient discharged on levofloxacin 750mg oral daily for 7 days.On (b)(6) 2020¿patient recovering well status post left hip infected hematoma irrigation and debridement.This case used a cardinal health general surgery pack sbac2dsdcc that contained either gown a9541nae or 90370nba.

Manufacturer Narrative

Supplemental mdr is being filed since the results from the investigation are ready.The kit that was reported to cardinal health for this incident contains two possible gowns manufactured by two different suppliers.Since a work order was not provided by customer, quality analysis team performed a review of orders manufactured in the last six months to determine the gowns used in each kit.Based on our analysis the two gowns consistently used in these kits are a9541nae- gown,surgical,astound,x-large,fabric reinforced,ns or 90370nba - gown,surgical,w/towel,x-large,unreinf,wrapped,ns.Supplier a is (b)(4): based on supplier investigation for gown a9541nae the device history record could not be reviewed as a lot number was not provided.No sample was available for investigation.Supplier reviewed their environment control, temperature/humidity, differential pressure, air exchange time, particle, settling microbe, planktonic bacteria and surface microorganisms monitor/test record from (b)(6) 2019, all within the specification.There is no abnormal found.According to their production environment control procedure, each workshop shall do the routine daily clean and comprehensive clean once or twice a week.From the investigation, the root cause could not be determined.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.Supplier b is (b)(4): at the time of this investigation no sample or lot number were provided for gown 90370nba,.Many attempts were made to retrieve investigation results from the supplier, (b)(4), however we have learned they have de-listed their fda registration and they are no longer in business since january 2020.As such, we do not expect to receive any feedback or investigation results from the supplier.Cardinal health is no longer doing business with this supplier.Cardinal health has initiated a formal recall (event #: (b)(4)) to the fda of certain cardinal health convenience kits that contained the gowns manufactured by the supplier (b)(4).No further action will be taken at his time, but we will continue to monitor our complaint database for any similar reports.

• Brand Name: GENERAL SURGERY PACK (DSDCB)468
• 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
• MDR Report Key: 9862948
• MDR Text Key: 196546102
• Report Number: 1423537-2020-00441
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10888439208214
• UDI-Public: 10888439208214
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SBAC2DSDCC
• Device Catalogue Number: SBAC2DSDCC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 75 YR
• Patient Weight: 79