MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-02-25 for 10 ML BD POSIFLUSH? NORMAL SALINE SYRINGE 306547 manufactured by Bd Medical (bd West) Medical Surgical.
[187404647]
The initial reporter also notified the fda on 5 february, 2020. Medwatch report # unknown. Report source other: medwatch report. Investigation summary: 20 samples were received. They came in sealed packaging flow wrap. They were visually inspected. No damage or any other defect was noticed. The tip cap torque was measured finding them within specification. The tip caps were removed and the luer lok was inspected under the microscope finding no defects or damages. 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. 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. Investigation conclusion: this is the 1st complaint for lot # 9351505 for this type of defect or symptom. There was no documentation for this type of defect during the entire production run of this batch. Root cause description: failure mode was not verified and root cause is undetermined. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[187404648]
It was reported that 10 ml bd posiflush? Normal saline syringe was damaged and leaked. This was discovered during use. The following information was provided by the initial reporter: reported via medwatch: patient having labs drawn and plastic tip on the saline syringes were not smooth and would not screw tightly into the hub of the heplock. This allowed the flush to leak and allowed blood to backflow into the tubing. No injury noted to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00178 |
| MDR Report Key | 9751983 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2019-12-17 |
| Date Added to Maude | 2020-02-25 |
| 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 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 | 10 ML BD POSIFLUSH? NORMAL SALINE SYRINGE |
| Generic Name | SALINE, VASCULAR ACCESS FLUSH |
| Product Code | NGT |
| Date Received | 2020-02-25 |
| Returned To Mfg | 2020-02-05 |
| Model Number | 306547 |
| Catalog Number | 306547 |
| Lot Number | 9351505 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-25 |