MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-19 for BD POSIFLUSH? NORMAL SALINE SYRINGE 306547 manufactured by Bd Medical (bd West) Medical Surgical.
[186322436]
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. 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. Based on no sample, the investigation concluded, bd was not able to verify the indicated failure. A device history record review was completed with zero defects found. No quality notifications were written for this batch, nor for the associated assembly batches. Root cause: undetermined. Investigation conclusion: this is the 1st complaint for lot # 9290832 for this type of defect or symptom. There was no documentation for this type of defect during the entire production run of this batch. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[186322437]
It was reported after use of the bd posiflush? Normal saline syringe there was medical intervention- intend to consult a physician. The following information was provided by the initial reporter: "when using the posiflush to clean catheter, customer notices that co2 levels drop". Customer stated that he did not intend for his phone call to be a complaint. He was just looking for information on the product. He had no additional information to give and does not want any further communication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00276 |
| MDR Report Key | 9857073 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-10-17 |
| Date Added to Maude | 2020-03-19 |
| 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 BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Street | 1852 10TH AVENUE |
| Manufacturer City | COLUMBUS NE 68601 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68601 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD POSIFLUSH? NORMAL SALINE SYRINGE |
| Generic Name | INTRAVASCULAR CATHETER |
| Product Code | NGT |
| Date Received | 2020-03-19 |
| Model Number | 306547 |
| Catalog Number | 306547 |
| Lot Number | 9290832 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Address | 1852 10TH AVENUE COLUMBUS NE 68601 US 68601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-19 |