MAUDE Adverse Event Report: SC003 SC-FORT MILL PACEMAKER (PPRVM)133; GENERAL SURGERY TRAY (KIT)

Model Number	SANHDPPRVN
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, the device history record could not be reviewed as the lot number was not provided.No sample was provided for evaluation, only photos showing lint on the gloves.The supplier checked on the retained sample.The average linting data was (b)(4) pieces and within limits (b)(4).The operating room towel is made of cotton, so lint is born and inevitable.The intended use of operating room towel is to be used for applying medication to or absorbing small amounts of body fluids from a patient's body surface.Measures to better control and improve linting have been implemented.A suction process was added before products' final folding and operators perform this activity according to standard operation procedure requirements.In the folding process, one cloth bag protects 100 pieces of semi-finished products to avoid linting stuck onto the products during product transfer.The supplier simulated wiping a wet glove with the sample and found no cotton lint.Based on the investigation, all linting test data is within the acceptable range.There is no abnormal situation that has happened in production.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.Corrective action & preventive action (capa (b)(4)) was initiated in 22nd jan 2018 to address this quality issue.We will continue to monitor for this type of incident.
Event or Problem Description
The customer reported that fibers from the blue operating room towels pwtb03-stma are coming in the pacemaker pack/sanhdpprvn and were found on the staff¿s gloves.It was reported that there was no patient injury.No patient demographics or additional qualifying information would be provided by the customer.The mdr will be filed for malfunction at this time.

• Brand Name: PACEMAKER (PPRVM)133
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): SC003 SC-FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 8332885
• Report Number: 1423537-2019-00270
• Device Sequence Number: 11320174
• Product Code: LRO
• UDI-Device Identifier: 10888439196788
• UDI-Public: 10888439196788
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SANHDPPRVN
• Device Catalogue Number: SANHDPPRVN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/12/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other