MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-07-10 for TIPCAP, LUER LOCK, GREEN, 100 H93869100 manufactured by Availmed.
[113638856]
This event occurred on an unspecified date in (b)(6) 2018. (b)(6). Device manufacturer address line 2: (b)(4). Should additional relevant information becomes available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[113638857]
It was reported that white particulate matter (pm) was observed in the packaging of a discpac self-righting luer lock tip cap. The pm was observed prior to patient use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[127532021]
The actual sample and companion samples were returned for evaluation. Visual inspection was performed and it was noted that loose particulate matter (pm) was observed in the inside surface of the luer lock tip caps of two samples. Further particulate matter analysis determined the white particulate on both samples is consistent with mannitol. The reported condition was verified. The cause of the reported condition could not be determined. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[127532022]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-04247 |
| MDR Report Key | 7675388 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-10 |
| Date of Report | 2018-11-13 |
| Date Mfgr Received | 2018-11-07 |
| Date Added to Maude | 2018-07-10 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | AVAILMED |
| Manufacturer Street | C. INDUSTRIAL LT 001 MZ 105 SEE H10 |
| Manufacturer City | TIJUANA, BAJA CALIFORNIA 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TIPCAP, LUER LOCK, GREEN, 100 |
| Generic Name | DISPENSER, LIQUID MEDICATION |
| Product Code | KYX |
| Date Received | 2018-07-10 |
| Returned To Mfg | 2018-08-13 |
| Model Number | NA |
| Catalog Number | H93869100 |
| Lot Number | 60075448 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVAILMED |
| Manufacturer Address | TIJUANA, BAJA CALIFORNIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-10 |