MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-05-04 for TAUT INTRADUCERS 10/BX7.5 FR X 3.5 PI-93 manufactured by Teleflex Medical.
[74412207]
(b)(4). The device history review for the product taut introducers 10/bx7. 5 fr x 3. 5, lot #73h1600183 investigation did not show issues related to the complaint. The device has not been returned for investigation at this time. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[74412208]
The luer lock tip loosened and fell into the patient's abdomen during the procedure. The tip was retrieved. There was no patient injury or consequence.
Patient Sequence No: 1, Text Type: D, B5
[80527852]
(b)(4). The customer returned one unit pi-93 taut intraducers 10/bx 7. 5 fr x 3. 5 for investigation. Only the check valve was returned. A piece of the check valve fell out and was returned loose. No other defects or anomalies were observed. It could not be determined what caused the piece to fall out of the check valve since the rest of the device was not returned. (b)(4). 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. " a corrective action is not required at this time as it cannot be determined what caused the complaint issue. Only the check valve was returned with a piece of the check valve that fell out. Since the other remarks: rest of the actual sample was not returned; it could not be determined how the piece of the check valve fell out of the device. The reported complaint of "fell apart during use" was confirmed based upon the sample received. The customer only returned the check valve and a piece of the check valve that fell out. The rest of the device was not returned. It could not be determined what caused the piece to fall out of the check valve since the rest of the device was not returned. A device history record review was performed on the device with no evidence to suggest a manufacturing related cause. It cannot be determined what caused the reported complaint issue. No further action will be taken.
Patient Sequence No: 1, Text Type: N, H10
[80527853]
The luer lock tip loosened and fell into the patient's abdomen during the procedure. The tip was retrieved. There was no patient injury or consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-00445 |
| MDR Report Key | 6543897 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-04 |
| Date of Report | 2017-04-11 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-05-31 |
| Device Manufacturer Date | 2016-08-31 |
| Date Added to Maude | 2017-05-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAUT INTRADUCERS 10/BX7.5 FR X 3.5 |
| Generic Name | CATHETER, PERITONEAL |
| Product Code | GBW |
| Date Received | 2017-05-04 |
| Returned To Mfg | 2017-05-03 |
| Catalog Number | PI-93 |
| Lot Number | 73H1600885 |
| Device Expiration Date | 2019-09-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-04 |