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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL TAUT INTRADUCERS 10/BX7.5 FR X 3.5; CATHETER, PERITONEAL
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TELEFLEX MEDICAL TAUT INTRADUCERS 10/BX7.5 FR X 3.5; CATHETER, PERITONEAL Back to Search Results
Catalog Number PI-93
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/05/2018
Event Type  malfunction  
Manufacturer Narrative
(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 as the device was being used the small silicone washer separated from the taut introducer peritoneal catheter and fell onto the sterile field following the use of the cholangiogram catheter.The washer was removed intact from the sterile field.
 
Manufacturer Narrative
Qn#(b)(4).Medwatch report # (b)(4) per dhr the product taut introducers 10/bx7.5 fr x 3.5 lot # 73d1700302 was manufactured on 04/24/2017 a total of (b)(4) pieces.Lot was released on 04/27/2017.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.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
 
Event Description
It was reported that as the device was being used the small silicone washer separated from the taut introducer peritoneal catheter and fell onto the sterile field following the use of the cholangiogram catheter.The washer was removed intact from the sterile field.
 
Manufacturer Narrative
Qn#(b)(4).Medwatch report #5080440 the customer returned one unit pi-93 taut intraducers 10/bx 7.5 fr x 3.5 for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed that only the check valve and intraducer catheter/catheter hub were returned.The needle hub/intraducer stylet and protector were not returned.It was observed that the clear disc is missing from the check valve.The clear disc was not returned.The disc could have fallen out of the check valve due to the catheter getting stuck on it and pulling it out.However , it could not be confirmed whether or not this was the case.The catheter that was used was not returned.The sample has been sent to the supplier of the product and a non-conformance has been opened to further investigate this complaint issue.The sample has been sent to the supplier of the product and a non-conformance has been opened to further investigate this complaint issue.The ifu for this product, l03610, was reviewed as a part of this complaint investigation.The ifu states, "insert the intraducer assembly through the abdominal wall using a continuous, controlled, slow, forward motion.Under direct visualization using the laparoscope, penetrate the peritoneum until the catheter tip is just visible within the peritoneal cavity." "immediately upon entry into the peritoneal cavity, hold the intraducer in place and withdraw the needle completely.Remove check valve from needle hub and reinstall on intraducer catheter hub." the reported complaint of "seal detached" was confirmed based upon the sample received.The clear disc from the check valve was missing from the device and was not returned.The disc could have fallen out of the check valve due to the catheter getting stuck on it and pulling it out.However , it could not be confirmed whether or not this was the case.The catheter that was used was not returned.It cannot be determined what caused the reported complaint issue.However, the sample has been sent to the supplier of the product and a non-conformance has been opened to further investigate this complaint issue.
 
Event Description
It was reported that as the device was being used the small silicone washer separated from the taut introducr peritoneal catheter and fell onto the sterile field following the use of the cholangiogram catheter.The washer was removed intact from the sterile field.
 
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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 Key8124998
MDR Text Key129057491
Report Number3003898360-2018-00975
Device Sequence Number1
Product Code GBW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/27/2020
Device Catalogue NumberPI-93
Device Lot Number73D1700302
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2018
Date Manufacturer Received01/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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