MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-22 for MEDRAD SWABBABLE VALVE TRANSFER SET 60729202 SVTS manufactured by Bayer Medical Care.
[70881159]
Product analysis received and examined the returned product. Visual examination of the returned product confirmed the presence of particulate inside the tubing. Examination of the particulate found it to be partially embedded within the tubing wall. The particulate measures approximately 1. 25 cm in length. Our investigation determined that the particulate noted in the syringe was introduced during the manufacturing process. The syringe kit instructions for use instructs the user to "visually inspect contents and package before each use". This visual inspection is to ensure particulates are noticed and mitigated, which is what occurred in this reported instance.
Patient Sequence No: 1, Text Type: N, H10
[70881160]
The following information was obtained from the customer: the customer reported black foreign body inside the transfer set tubing. No injury or adverse event was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520313-2017-00018 |
| MDR Report Key | 6424985 |
| Date Received | 2017-03-22 |
| Date of Report | 2017-03-22 |
| Date of Event | 2017-02-24 |
| Date Mfgr Received | 2017-02-24 |
| Date Added to Maude | 2017-03-22 |
| 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. SUSAN SHERWIN |
| Manufacturer Street | 1 BAYER DRIVE |
| Manufacturer City | INDIANOLA PA 15051 |
| Manufacturer Country | US |
| Manufacturer Postal | 15051 |
| Manufacturer Phone | 7249408678 |
| Manufacturer G1 | BAYER MEDICAL CARE |
| Manufacturer Street | 1 BAYER DRIVE |
| Manufacturer City | INDIANOLA PA 15051 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15051 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDRAD SWABBABLE VALVE TRANSFER SET |
| Generic Name | TUBING, FLUID DELIVERY |
| Product Code | FPK |
| Date Received | 2017-03-22 |
| Returned To Mfg | 2017-03-16 |
| Model Number | 60729202 |
| Catalog Number | SVTS |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYER MEDICAL CARE |
| Manufacturer Address | 1 BAYER DRIVE INDIANOLA PA 15051 US 15051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-22 |