MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-05-15 for PLASMAX MINI KIT W/30ML ACDA N/A 800-0516 manufactured by Zimmer Biomet, Inc..
[108302099]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Discarded.
Patient Sequence No: 1, Text Type: N, H10
[108302100]
It was reported that the tip of the syringe broke off into the plasmax tube. The defective tube was thrown away in biohazard. There was a 20 minute delay because the patient? S blood had to be redrawn. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
[134246006]
The reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. The root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Product not returned.
Patient Sequence No: 1, Text Type: N, H10
[134246007]
No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-03368 |
| MDR Report Key | 7515685 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-05-15 |
| Date of Report | 2019-01-23 |
| Date of Event | 2018-04-18 |
| Date Mfgr Received | 2019-01-18 |
| Date Added to Maude | 2018-05-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLASMAX MINI KIT W/30ML ACDA |
| Generic Name | SUPPLIES, BLOOD-BANK |
| Product Code | KSS |
| Date Received | 2018-05-15 |
| Model Number | N/A |
| Catalog Number | 800-0516 |
| Lot Number | NI |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-15 |