MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-20 for BD POSIFLUSH? HEPARIN LOCK FLUSH SYRINGE 306423 manufactured by Bd Medical (bd West) Medical Surgical.
[131176173]
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation: one photo sample was received for evaluation. The syringe has no barrel label, therefore failure mode is verified. This was most likely due to a process variation in the plunger rod labeler machine. This is the first complaint for the lot#s 814600n and 805088n for the same defect or symptom. There was no documentation of issues for the complaint of batch #s 814600n and 805088n during these production runs. 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.
Patient Sequence No: 1, Text Type: N, H10
[131176174]
It was reported with the use of the bd posiflush? Heparin lock flush syringe there was an issue with no labeling on the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2018-00756 |
| MDR Report Key | 8186835 |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-11-29 |
| Date Mfgr Received | 2018-11-29 |
| Date Added to Maude | 2018-12-20 |
| 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 | 8015652845 |
| 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 | 0 |
| Brand Name | BD POSIFLUSH? HEPARIN LOCK FLUSH SYRINGE |
| Generic Name | FLUSH |
| Product Code | NZW |
| Date Received | 2018-12-20 |
| Catalog Number | 306423 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| 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 | 2018-12-20 |