MAUDE Adverse Event Report: TELEFLEX MEDICAL TAUT INTRADUCERS 10/BX7.5 FR X 3.5; CATHETER, PERITONEAL

Catalog Number PI-93

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the small silicone washer fell out of the taut introducer peritoneal catheter into the patient's abdomen.The surgeon was able to retrieve the washer.

Event Description

It was reported that the small silicone washer fell out of the taut introducer peritoneal catheter into the patient's abdomen.The surgeon was able to retrieve the washer.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product taut intraducers 10/bx7.5 fr x 3.5 lot # 73e1700181 was manufactured on 05/15/2017 a total of 800 pieces.Lot was released on 05/19/2017.Dhr investigation did not show issues related to complaint.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.

• Brand Name: TAUT INTRADUCERS 10/BX7.5 FR X 3.5
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8173974
• MDR Text Key: 130653709
• Report Number: 3003898360-2018-01042
• Device Sequence Number: 1
• Product Code: GBW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: PI-93
• Device Lot Number: 73E1700181
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1