MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-18 for SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL 306547 manufactured by Bd Medical (bd West) Medical Surgical.
[186325239]
Investigation summary: 2 samples were received. They came in a plastic bag. They are contaminated with blood. The stopper rod has been removed from the syringe. For safety reasons, no further analysis can be done. The syringe is designed to flush the iv lines. The plunger rod shouldn? T be pulled back, neither should it be removed from the syringe. 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 2nd complaint for lot # 9351520 for this type of defect or symptom. Previous complaint (b)(4). There was no documentation for this type of defect during the entire production run of this batch. Root cause description: the syringe is designed to flush the iv lines. The plunger rod shouldn? T be pulled back, neither removed from the syringe. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[186325240]
It was reported that syr 10ml pump compatible saline 10ml fil stopper separated from the plunger. The following information was provided by the initial reporter: "it was reported that the plastic piece detaches from the rubber stopper. Per email: we have been having issues with the saline syringes. When pulling back on them, the plastic piece comes off and the rubber plunger stays in there. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00270 |
| MDR Report Key | 9850652 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-12-17 |
| Date Added to Maude | 2020-03-18 |
| 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 | SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL |
| Generic Name | SALINE, VASCULAR ACCESS FLUSH |
| Product Code | NGT |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-03-03 |
| Model Number | 306547 |
| Catalog Number | 306547 |
| Lot Number | 9351520 |
| 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 | 2020-03-18 |