MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-07-17 for PLEURX PERITONEAL CATHETER MINI KIT 50-9050 manufactured by Carefusion, Inc.
[114145513]
(b)(4) initial emdr submission. A follow up emdr will be submitted if additional information becomes available. (b)(4). The lot number was unknown on this complaint, therefore we are unable to perform a device history record review. No complaint sample was provided for evaluation. Consequently, the investigation was not able to confirm the reported failure mode based on a complaint sample evaluation. The investigation was not able to identify any contribution from the factors noted above. Based on the complaint investigation, a probable root cause could not be identified since no complaint sample was provided for evaluation, no lot information was included in the complaint report, and no contribution was identified from the manufacturing process. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends.
Patient Sequence No: 1, Text Type: N, H10
[114145514]
This patient of (b)(6) hospital was referred to me for a tunnelled ascitic drain that i inserted on (b)(6) 2018. She started to have severe back pain after she drained her ascitic fluid 1-2 days after the insertion. She ended up needing to have morphine for her pain. I reviewed her today and had an xray which shows the tip of the is pointing upwards at l1 level and likely behind the liver. The calcification seen on the xray is in fact calcified left liver lobe. I have spoken to her and she is keen to have it ex-planted and replaced with a new one. I am also keen to do so as she is relying heavily on morphine and i so not want her to suffer the pain from this drain insertion. My plan is to perform this procedure with aid of xray just to ensure the tip is in the pelvis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625685-2018-00028 |
| MDR Report Key | 7693422 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-07-17 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-06-26 |
| Date Mfgr Received | 2018-06-26 |
| Date Added to Maude | 2018-07-17 |
| 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 | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 400 EAST FOSTER RD |
| Manufacturer City | MANNFORD OK 74044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74044 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLEURX PERITONEAL CATHETER MINI KIT |
| Generic Name | PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING |
| Product Code | PNG |
| Date Received | 2018-07-17 |
| Catalog Number | 50-9050 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 400 EAST FOSTER RD MANNFORD OK 74044 US 74044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-17 |