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.
[74419412]
(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
[74419413]
The diaphragm have become loose and fell into the patient's abdomen during the procedure. There was no patient injury or consequence.
Patient Sequence No: 1, Text Type: D, B5
[80322858]
Qn#(b)(4). The customer returned four units pi-93 taut introducers 10/bx 7. 5 fr x 3. 5 for investigation. The customer returned three representative samples and the check valve of the actual sample. The rest of the actual sample was not returned. The returned devices were visually examined with and without magnification. Visual examination of the returned devices revealed that they appear typical. All of the returned devices appeared to be fully intact. No defects or anomalies were observed. Reference files (b)(4) for investigation photos. Functional inspection was performed on the returned samples. The representative samples were each tested for proper assembly. No issues were found with the assembly as the check valve was able to attach to both the needle hub and the catheter hub for all three representative samples. Since the entire actual sample was not returned, the check valve was tested with the representative samples. The check valve of the actual sample was able to successfully attach to the needle hub and catheter hub of the representative samples. No issues were found with the representative samples. Since only the check valve was returned, it could not be determined if the actual sample fell apart. Other remarks: the ifu for this product, l03610, was reviewed as a part of this complaint investigation. The ifu states, "insert the introducer 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 introducer in place and withdraw the needle completely. Remove check valve from needle hub and reinstall on introducer catheter hub. " a corrective action is not required at this time as the reported complaint could not be confirmed since the entire actual sample was not returned. Only the check valve was returned along with three representative samples. No issues were found with the representative samples. The reported complaint of "fell apart during use" was not confirmed based upon the samples received. The customer returned three representative samples and the check valve of the actual sample. Upon functional inspection, no issues were found with any of the returned devices. A device history record review was performed on the device with no evidence to suggest a manufacturing related cause. Since the entire actual device was not returned and no issues were found with what was returned, the reported complaint issue could not be confirmed. No further action will be taken. Results: root cause is unknown.
Patient Sequence No: 1, Text Type: N, H10
[80322859]
The diaphragm have become loose and fell into the patient's abdomen during the procedure. There was no patient injury or consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-00471 |
| MDR Report Key | 6543928 |
| 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 |