MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE MCLAREN CATH LAB PACK (CLMLA)139; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SANRPCLMLB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, device history record (dhr) review did not indicate any exception that could lead to the reported incident.No sample returned for investigation.Supplier checked on their retained sample and found no linting phenomenon.According to the supplier, there is no change of the raw material and the production process of the gauze sponge.They always control the linting as the main defect during the process inspection and finished product inspection.From the investigation, there is no abnormal situation happened in production, retained sample and dhr.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer reported the gauze c-nsg4416a from the cath lab pack sanrpclmlb is linting and has other loose particles.No adverse event was reported.No further details were provided by the customer when requested.Report being filed for potential risk to patient.

• Brand Name: MCLAREN CATH LAB PACK (CLMLA)139
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY 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: 12160788
• Report Number: 1423537-2021-00649
• Device Sequence Number: 4722959
• Product Code: OEQ
• UDI-Device Identifier: 10888439840100
• UDI-Public: 10888439840100
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SANRPCLMLB
• Device Catalogue Number: SANRPCLMLB
• Device Lot Number: 631748
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other