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 2020-03-19 for 10 ML BD POSIFLUSH? NORMAL SALINE SYRINGE 306595 manufactured by Bd Medical (bd West) Medical Surgical.
[186324459]
Investigation summary: no samples were received. No photos were provided. It could have happened that a jam occurred at the plunger rod assembly process inducing damages to the barrel. 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: 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. Root cause description: posiflush assembly line. Plunger rod assembly. It could have happened that a jam occurred at the plunger rod assembly process inducing damages to the barrel. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[186324460]
It was reported that 10 ml bd posiflush? Normal saline syringe was broken and leaked. This was discovered before use. The following information was provided by the initial reporter: after opening the outer package, the flush was broken and the liquid leaked out, it was not sure that this product was able to use or not.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00277 |
| MDR Report Key | 9857072 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-06-06 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2018-02-15 |
| 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 |
| 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 | SYRINGE |
| Product Code | FMF |
| Date Received | 2020-03-19 |
| Catalog Number | 306595 |
| Lot Number | 8046832 |
| Device Availability | N |
| 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 |