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

Catalog Number 81-080408

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

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 (81-080408) failed during use.The customer reported the catheter started leaking after less than six weeks of use.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, a defective sample was received.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 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 silicone catheter portion of this device is supplied by (b)(4).Therefore, 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

A foley catheter with a temperature sensor was leaking from the middle of the tubing at about the height where plaster was placed for fixation.The catheter was placed less than six weeks ago.The leaking catheter was removed and replaced with a new one.

Manufacturer Narrative

Root cause: the catheter is supplied by (b)(4), and therefore, a supplier corrective action request (scar) was issued to (b)(4).In scar response, (b)(4) stated, during its manufacturing process, every batch of catheters undergoes tensile strength testing to detect weak shaft-funnel connections.In this case, the batch number is unknown, and therefore, (b)(4) was unable to check the tensile strength results.The complaint part number is an 8 french catheter, which is a thin shaft of 2.7 mm in diameter.If the shaft is pulled with excessive force, it can be torn off of the tunnel.(b)(4) states it is unable to confirm the complaint as the shaft could have been torn following excessive force during use.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 ((b)(4)) failed during use.The customer reported the catheter started leaking after less than six weeks of use.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, a defective sample was received.Pictures of the defective catheter were sent to the supplier for evaluation.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 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 catheter 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.Follow up attempts were made and a response was received november 25, 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

A foley catheter with a temperature sensor was leaking from the middle of the tubing at about the height where plaster was placed for fixation.The catheter was placed less than six weeks ago.The leaking catheter was removed and replaced with a new one.

• 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 highway33 south; new tazewell TN 37825
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5921465
• MDR Text Key: 53718902
• Report Number: 2320762-2016-00018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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