MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-09-07 for DEVON 31160545 manufactured by Covidien.
[85160441]
Submit date: 09/07/17. An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[85160442]
The customer states that the leaking markers are causing stains.
Patient Sequence No: 1, Text Type: D, B5
[113436573]
One hundred decontaminated samples outside of the original package without a lot number was received for evaluation. A sample analysis was performed; as part of the analysis the sample was visually inspected according to the product specification. The samples appear to have a leakage through the air holes. The reported condition by the customer was confirmed. The skin marker is a purchased component manufactured by an approved vendor. The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer. The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process. The component skin marker is produced by external supplier and the assembly process consists of a pick and place operation. There is no additional inspection on the line to detect the condition reported. The following root cause was provided by our supplier: ink leakage was from air hole for all 23 samples that showed ink leakage. The possible reasons for ink leakage from air holes are: impact from dropping. Decompression. Based on the state of returned samples and test results, we concluded that the leakage oc curred due to an impact such as dropping. A production notification was issued to all personnel to ensure that they are aware on the condition reported by the customer. The following corrective actions were implemented by our supplier: the possible reason for dropping in production site maybe at production line or during transportation. However, it is unlike that dropping occurs in the line. We palletize the products so it is unlike to be dropped during transportation. Please instruct your working members and the customer to handle with care. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2017-05158 |
| MDR Report Key | 6849508 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-09-07 |
| Date of Report | 2018-02-13 |
| Date Mfgr Received | 2017-08-15 |
| Date Added to Maude | 2017-09-07 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 1113 CUIDAD |
| Manufacturer City | TIJUANA,NA 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEVON |
| Generic Name | MARKER, SKIN |
| Product Code | FZZ |
| Date Received | 2017-09-07 |
| Returned To Mfg | 2017-08-28 |
| Model Number | 31160545 |
| Catalog Number | 31160545 |
| Lot Number | 1716478964 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 1113 CUIDAD TIJUANA,NA 22444 MX 22444 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-07 |