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 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review could not be conducted since the lot number was not provided.The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during use of the taut introducer there was an issue with the little white valve separating from the rest of the device and falling into the patient's abdomen during a laparoscopic case.The physician was able to remove the valve from the patient's abdomen.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).Dhr review could not be conducted since the lot number was not provided.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 the sample appears used as there is biological material present on the device.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.No other defects or anomalies were observed.Reference files (b)(4) for investigation photos.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 other remarks: cavity, hold the intraducer in place and withdraw the needle completely.Remove check valve from needle hub and reinstall on intraducer catheter hub." a corrective action is not required at this time as it cannot be determined what caused the complaint issue.The clear disc in the check valve was missing from the check valve.The reported complaint of "broke off in patient" 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.

Event Description

It was reported that during use of the taut introducer there was an issue with the little white valve separating from the rest of the device and falling into the patient's abdomen during a laparoscopic case.The physician was able to remove the valve from the patient's abdomen.The patient's condition was reported as fine.

• 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
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 7348587
• MDR Text Key: 102739031
• Report Number: 3003898360-2018-00134
• Device Sequence Number: 1
• Product Code: GBW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PI-93
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1