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 2020-03-16 for BD POSIFLUSH? NORMAL SALINE SYRINGE 306547 manufactured by Bd Medical (bd West) Medical Surgical.
[186725163]
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: 1 sample was received. It doesn? T have the packaging flow wrap. It has the plunger rod-rubber stopper and no tip cap. The plunger rod-rubber stopper is at 4ml. It has 2ml of a solution. The sample was tested for sustaining force. It measured 14. 8n. The specification is <20n. 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: failure mode was not verified. This is the 1st complaint for lot # 9274698 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: root cause is undetermined. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[186725164]
It was reported that the bd posiflush? Normal saline syringe plunger would only push out "6 ml" of the 10 ml in the syringe during use. The syringe was removed from the iv to attempt to push out the remainder of the saline, but the plunger became "stuck" in the process. The following information was provided by the initial reporter: " saline syringe attached to iv attempting to push solution but would only administer 6ml of the 10 ml in syringe. Syringe removed from iv and attempted to push saline out of syringe but plunger is stuck and unable to be pushed any further. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00253 |
| MDR Report Key | 9836796 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-10-01 |
| Date Added to Maude | 2020-03-16 |
| 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 | BD POSIFLUSH? NORMAL SALINE SYRINGE |
| Generic Name | SALINE VASCULAR ACCESS FLUSH |
| Product Code | NGT |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-03-09 |
| Model Number | 306547 |
| Catalog Number | 306547 |
| Lot Number | 9274698 |
| 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 | 2020-03-16 |