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 2020-03-05 for SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD 306499 manufactured by Bd Medical (bd West) Medical Surgical.
[185224535]
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[185224536]
It was reported that an unspecified number of syr 10 ml fil saline shortlength plunger rod experienced stopper separation from the plunger. It has not been specified whether the product defect was noted prior to, during, or after use. The following information was provided by the initial reporter: material no. : 306499 batch no. : 9018605. Verbatim: i'm not sure what is happening at bd with the manufacturing of their syringes but we are now getting reports of the flushes having problems. The black piece is coming off of the plunger. This is the same problem reported with the 20ml syringe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00212 |
| MDR Report Key | 9791589 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-01-18 |
| Date Added to Maude | 2020-03-05 |
| 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 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD |
| Generic Name | INTRAVASCULAR CATHETER |
| Product Code | NGT |
| Date Received | 2020-03-05 |
| Returned To Mfg | 2020-03-04 |
| Catalog Number | 306499 |
| Lot Number | 9018605 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-03-05 |