MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. FOLEY CATHETER, 400 SERIES 8 FR; CATHETER, UPPER URINARY TRACT

Catalog Number 81-080408

Device Problems No Display/Image (1183); No Device Output (1435)

Patient Problem Fever (1858)

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint ((b)(4)) was received reporting that a foley catheter with a temperature sensor ((b)(4)) failed during use.The customer reported the temperature portion of the device stopped functioning.This report is one of seven total filed by the reporting customer in reference to the finished good number.According to the initial complaint report, these incidents occurred over a period of several months, and the customer chose to file them at one time in a batch.No lot numbers were provided, and a sample was available for only one of the seven reported incidents.For this incident, neither a lot number nor defective sample was available.A shipping inquiry by box identification showed that four cases of finished good (b)(4) were ordered by the reporting customer in 2013 and shipped on july 11, 2013.The lot number shipped to the customer was 32608900, which was manufactured july 2, 2013.Review of this work order shows no discrepancies that would have contributed to the reported issue.The finished good assembly consists of the following raw materials that are assembled as detailed below: raw material part number (b)(4) (foley catheter wire supplied by (b)(4)) is received at the manufacturing plant.After receiving, a connector is molded to the wire set and a continuity test is conducted to ensure the thermistor chip has not had any affectation.The raw material is converted to part number 74-12088cr (molded foley catheter wire set) and shipped to (b)(4).Once (b)(4) has received the product, the part is converted into part number 74-12089 (foley catheter 8 fr) and shipped to the plant in (b)(4) for packaging.It is here the part number is converted to the finished good part number of (b)(4).The two most recent work orders for raw material part (b)(4) were reviewed and no rejects were reported during the manufacturing process.Because the raw material wire is supplied by (b)(4), a supplier corrective action request (scar) was issued to the vendor on august 29, 2016.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

The temperature monitoring function of the foley catheter with a temperature sensor stopped working after five days of use.This is an issue as the patient in question is a liver transplantation patient on whom rectal temperature cannot be taken.

Manufacturer Narrative

Root cause: the raw material wire is supplied by (b)(4), and therefore, a supplier corrective action request (scar) was issued to (b)(4).In scar response, (b)(4) stated a proper investigation could not be performed because samples were not returned for evaluation and batch numbers were unknown.As part of the manufacturing process, catheters are 100 percent tested for temperature reading accuracy.Corrective action: in its scar response, (b)(4) indicated a corrective action has not been taken.Investigation summary an internal complaint ((b)(4)) was received reporting that a foley catheter with a temperature sensor (81-080408) failed during use.The customer reported the temperature portion of the device stopped functioning.This report is one of seven total filed by the reporting customer in reference to the finished good number.According to the initial complaint report, these incidents occurred over a period of several months, and the customer chose to file them at one time in a batch.No lot numbers were provided, and a sample was available for only one of the seven reported incidents.For this incident, neither a lot number nor defective sample was available.A shipping inquiry by box identification showed that four cases of finished good 81-080408 were ordered by the reporting customer in 2013 and shipped on july 11, 2013.The lot number shipped to the customer was 32608900, which was manufactured july 2, 2013.Review of this work order shows no discrepancies that would have contributed to the reported issue.The finished good assembly consists of the following raw materials that are assembled as detailed below: * raw material part number 74-12088w (foley catheter wire supplied by (b)(4)) is received at the manufacturing plant.After receiving, a connector is molded to the wire set and a continuity test is conducted to ensure the thermistor chip has not had any affectation.The raw material is converted to part number 74-12088cr (molded foley catheter wire set) and shipped to (b)(4).* once (b)(4) has received the product, the part is converted into part number 74-12089 (foley catheter 8 fr) and shipped to the plant in (b)(4) for packaging.It is here the part number is converted to the finished good part number of 81-080408.The two most recent work orders for raw material part 74-12088cr were reviewed and no rejects were reported during the manufacturing process.The last shipment of raw material 74-12088cr was sent to (b)(4) in 2014.Because the raw material wire is supplied by (b)(4), a supplier corrective action request (scar) was issued to the vendor on august 29, 2016, and a due date of october 12, 2016, was assigned.A response was not received on this date.A corrective and preventive action point was opened and assigned to deroyal supply chain management to assist in obtaining a response from (b)(4).A scar response was received december 2, 2016.The failure mode and effects analysis (fmea) was reviewed and it was determined no updates are needed at this time.Preventive action: in its scar response, (b)(4) indicated a preventive action has not been taken at this time.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

The temperature monitoring function of the foley catheter with a temperature sensor stopped working after five days of use.This is an issue as the patient in question is a liver transplantation patient on whom rectal temperature cannot be taken.

• Brand Name: FOLEY CATHETER, 400 SERIES 8 FR
• Type of Device: CATHETER, UPPER URINARY TRACT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5921446
• MDR Text Key: 53792330
• Report Number: 2320762-2016-00017
• Device Sequence Number: 1
• Product Code: EYC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K041416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81-080408
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1