MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-01-15 for PLEURX DRAINAGE KIT 1000ML 50-7510 manufactured by Carefusion, Inc.
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(b)(6) initial emdr submission. A follow up emdr will be submitted if additional information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[187383586]
Hold shaneeka 4. 7product is defective 07jan2020: spoke to wife (b)(6) who reported that one bottle had the cap completely off. The next four bottles had no vacuum. She was concerned and took her husband to the er same day. She reported they did a chest x-ray. Radiology came and drained using 6 bottles and a total of 5. 5 l. Catheter is in patient's abdomen and was placed in (b)(6) 2019. Wife verified the x-ray was a chest x-ray which did not show any concerns. All bottles failed on same day. Husband usually drains 3000ml every other day. Last drain prior was as scheduled and there was no issues with the bottles from that drain. No additional intervention. Samples were thrown away. Wife will call back with lot details if available. Polc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680904-2020-00002 |
| MDR Report Key | 9590882 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-01-06 |
| Date Added to Maude | 2020-01-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | ZONA FRANCA LAS AMERICAS |
| Manufacturer City | SANTO DOMINGO |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLEURX DRAINAGE KIT 1000ML |
| Generic Name | PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING |
| Product Code | PNG |
| Date Received | 2020-01-15 |
| Catalog Number | 50-7510 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | ZONA FRANCA LAS AMERICAS SANTO DOMINGO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-15 |