MAUDE Adverse Event Report: TELEFLEX MEDICAL 100% SIL TIEMANN 2WAY 5CC

Catalog Number 171305160

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: the patient lost the catheter while being transferred to the toilet.There were no clinical consequences as a result of the incident.The catheter had been in place for nine days prior to the incident.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).Additional method: device history record for lot (14fe26) was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.One actual sample was returned for investigation.Based on observation the balloon of the sample was split.A simulation test was conducted with representative samples from production on the same catheter size and balloon volume.No deflation issue was observed.Balloons are still inflated to its normal condition and shape.In our current standard operating procedure, the products are subjected to 100% visual inspection, and leak test.Any defective raw balloon will be culled out before being sent to the next process.Based on the investigation conducted, we could not link any process discrepancy that could lead to the balloon split issue.Therefore, we could not confirm the complaint, as stated.

Event Description

Alleged event: the patient lost the catheter while being transferred to the toilet.There were no clinical consequences as a result of the incident.The catheter had been in place for nine days prior to the incident.The patient's condition was reported as fine.

• Brand Name: 100% SIL TIEMANN 2WAY 5CC
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5012245
• MDR Text Key: 24438259
• Report Number: 8040412-2015-00175
• Device Sequence Number: 1
• Product Code: FGH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 171305160
• Device Lot Number: 14FE26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1