MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-08 for DAR 350S19006 manufactured by Mallinckrodt Dar Srl.
[116863657]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[116863658]
According to the reporter, prior to use, the device had visible black spot seen with filter. The customer reported that there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[122528612]
The customer sent us one sample in its original opened packaging that showed black spots in the filter lid. Reported problem was verified. The customer complains the presence of black spots on the filter. The spots found on the plastic device are a typical molding defect. We perform an in process control with a sampling plan that for its nature allows a percentage of this kind of spot. We highlight that this kind of spot is incorporated into the (b)(4), and for this reason not risky for the patient. We underline that we run annual sessions of good manufacturing process(gmp) training to sensitize all our personnel on this kind of problem. Information has been added to the database and trends will continue to be monitored. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[132430443]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2018-00495 |
| MDR Report Key | 7763717 |
| Date Received | 2018-08-08 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-07-24 |
| Date Mfgr Received | 2018-09-04 |
| Date Added to Maude | 2018-08-08 |
| 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 | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER,CO MA 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MALLINCKRODT DAR SRL |
| Manufacturer Street | VIA GIACOMO BOVE 2/4/6/8 |
| Manufacturer City | MIRANDOLA 41037 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 41037 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DAR |
| Generic Name | FILTER, BACTERIAL, BREATHING-CIRCUIT |
| Product Code | CAH |
| Date Received | 2018-08-08 |
| Returned To Mfg | 2018-08-21 |
| Model Number | 350S19006 |
| Catalog Number | 350S19006 |
| Lot Number | 18B0674F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALLINCKRODT DAR SRL |
| Manufacturer Address | VIA GIACOMO BOVE 2/4/6/8 MIRANDOLA 41037 IT 41037 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-08 |