MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-22 for NON LATEX AIR RETENTION TIP 8825 manufactured by E-z-em Inc..
[96127687]
On 24-nov-2017: bracco distributor reported that there is a hard piece sticking out of the non latex air retention tip which could cause serious injury to the patient. There were 2 cases that were inspected and both cases had the same defect. The distributor reported there has been no reports of any incidents with any patients. On 15-dec-2017: bracco quality investigation results became available. Conclusion: based in the revision of the device history record (dhr) of the related lot numbers for subassemblies and finish good, no deviations, non-conformances and issues were found related to the reported failure. After evaluation the defect hardened thread was confirmed on the received sample. The analysis of the sources of variation for visual inspection not performed, lack of training, inspection not stated in the procedure and turn of thread not performed, these possible factors were previously mitigated by actions implemented on 15-jun-2017. The defective devices were manufactured before 15-jun-2017, when mitigation activities were not in place yet. Since there have been actions implemented to mitigate this failure mode, no capa will be created and no additional actions will be implemented at this moment. Company comments: this is a device malfunction with the use of the non latex air retention tip. The distributor reported that there was a hard piece sticking out of the non latex air retention tip which could cause serious injury to the patient during insertion. There was no patient or user/operator injury. However there may be the potential of injury, if the issue was to reoccur. Quality investigation confirmed that based on review of the device history record (dhr) of the related lot numbers for subassemblies and finish good, no deviations, non-conformances and issues were found related to the reported failure. Analysis of the sources of variation for: visual inspection not performed, lack of training, needed inspection not stated in procedure and turn of thread not performed are possible factors that were previously mitigated by actions implemented on june 15, 2017. Since the defective devices were manufactured before june 15th 2017, when mitigation activities were not yet in place to mitigate this failure mode, no capa will be created and no additional actions will be implemented at this time.
Patient Sequence No: 1, Text Type: N, H10
[96127688]
On 24-nov-2017, the bracco (b)(6) affiliate received a product complaint from a bracco distributor (b)(4). On 27-nov-2017, the report was forwarded to (b)(4) drug safety via email. The distributor (b)(4) reported that there was a defect described as a hard piece sticking out of the non latex air retention tip which could cause serious injury to the patient. There were 2 cases that were inspected by the distributor and both cases had the same defect. The distributor reported there have been no reports of any incidents with any patients. No further information was available for this report. On 15-dec-2017, bracco quality investigation results became available. This case is medically closed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411512-2017-00001 |
| MDR Report Key | 7143193 |
| Date Received | 2017-12-22 |
| Date of Report | 2017-11-24 |
| Date of Event | 2017-11-24 |
| Date Mfgr Received | 2017-11-24 |
| Device Manufacturer Date | 2015-03-26 |
| Date Added to Maude | 2017-12-22 |
| 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 | PATRICE MARCHILDON |
| Manufacturer Street | 155 PINELAWN ROAD, SUITE 230N |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 6095142522 |
| Manufacturer G1 | EZEM |
| Manufacturer Street | 155 PINELAWN ROAD, SUITE 230N |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NON LATEX AIR RETENTION TIP |
| Generic Name | ENEMA TIP |
| Product Code | FGD |
| Date Received | 2017-12-22 |
| Catalog Number | 8825 |
| Lot Number | 50872263, 50872264 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | E-Z-EM INC. |
| Manufacturer Address | 155 PINELAWN ROAD SUITE 230N MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-22 |