MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. PURE GOLD TIEMANN 5-15ML PTFE STR H 22; CATHETER, UROLOGICAL

Model Number	IPN051275
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
(b)(6) reporting that a 318122 as inserted in the or; on the next day upon evaluation/flushing, it slid out of the patient; the balloon was deflated.The foley was replaced; no harm to patient.I was given 3 lot numbers-not sure which, if any, are for this product (per reporter) kma21a0404, kma20t0435 and 20a13.
Event or Problem Description
Ohio state unv.Reporting that a 318122 as inserted in the or; on the next day upon evaluation/flushing, it slid out of the patient; the balloon was deflated.The foley was replaced; no harm to patient.I was given 3 lot numbers-not sure which, if any, are for this product (per reporter) kma21a0404, kma20t0435 and 20a13.
Additional Manufacturer Narrative
(b)(4).Lot number kma20t0435 does not exists in the system.Complaint reported that "a 318122 'as inserted in the or; on the next day upon evaluation/flushing, it 'slid' out of the patient-the balloon was deflated.The foley was replaced-no harm to patient.I was given 3 lot numbers-not sure which, if any, are for this product (per reporter) kma21a0404, kma20t0435 and 20a13." there was no sample returned for further investigation.As our own initiative, simulation test was done using representative sample from complaint sample tc20032538.Visual examination on the complaint sample tc20032538 did not reveal any obvious defect or abnormality.There was no sign of leak, kinking , clamp mark or collapse airline observed throughout the shaft.The catheters then were inflated with 10ml of water using a 10ml luer tip syringe.The balloons inflated without any difficulties faced.No latex particle or other foreign particle seen within the balloon.The inflation eye was normal and no collapse of the inflation airline observed.Leaving the inflated balloon for 30 minutes showed no sign of leak on any part of the catheter.Deflations of the balloons by connecting empty luer tip syringe barrel to the valve were smooth , spontaneous and complete.Repeat of inflation and deflation using the attached syringe gave similar observation with no problem experienced.There was no sample returned from complainant therefore further investigation could not be conducted to find out the real root cause of the leak as reported.From simulation test, no abnormality found on the representative sample from complaint (b)(6).Therefore , complaint could not be confirmed.

• Brand Name: PURE GOLD TIEMANN 5-15ML PTFE STR H 22
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11770644
• Report Number: 8040412-2021-00142
• Device Sequence Number: 14334565
• Product Code: KOD
• UDI-Device Identifier: 04026704303137
• UDI-Public: 04026704303137
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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: IPN051275
• Device Catalogue Number: 318122
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1