MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE HEART CATHETER PACK (HCSBC)180; GENERAL SURGERY TRAY (KIT)

Model Number SANHFHCSBD

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

From the device history record, lot number 20200220-23-sh was manufactured on 02/28/2020.No exception was recorded in the device history record that could lead to the reported incident.The linting test data was within the acceptable range, therefore, the root cause could not be determined from this investigation.At the time of this investigation the sample had not been returned to cardinal health.The complaint information was informed to the relevant personnel for their awareness.There is no action taken at this time, however, we will continue to monitor the trend of this type of incident.According to supplier, or towel is made of cotton, so cotton fiber is born.Supplier continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38 g/10 pieces).In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.

Event Description

Based on information received from the customer the pack reportedly contained towels with excess lint.Allegedly on the most recent occasion, the physician was intervening, and towel lint was found inside the tuohy needle.

Manufacturer Narrative

Based on supplier investigation, device history record review did not indicate any exception that could lead to the reported incident.The average linting data is 0.156 g / 10 pieces.From the investigation, there is no abnormal situation happened in production.Photos were provided for evaluation.The sample of or towel was packed in a bag, and no abnormal situation was found.Therefore, the root cause could not be determined.We will continue monitoring our customer complaints data base for this and any other issues reported of the same nature.According to supplier, or towel is made of cotton, so cotton fiber is born.Supplier continuously working with cah to better control the linting and have implemented several measures to improve it: a.Suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.B.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.C.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38 g/10 pieces).D.In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.

• Brand Name: HEART CATHETER PACK (HCSBC)180
• 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: 10148911
• MDR Text Key: 200844074
• Report Number: 1423537-2020-00467
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10888439335026
• UDI-Public: 10888439335026
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SANHFHCSBD
• Device Catalogue Number: SANHFHCSBD
• Device Lot Number: 424409
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other