MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-18 for BD? HEPARIN SYRINGE 306413 manufactured by Bd Medical (bd West) Medical Surgical.
[108998296]
Investigation: on (b)(6) 2018 two (2) samples were received. They are in the sealed packaging flow wrap. Both have the plunger rod-rubber stopper, the tip cap and saline solution. Both have the barrel label missing. Product within specification? There were no documented issues for the complaint of batch (b)(4) during this production run. All the inspections performed while manufacturing this batch were accepted; no rejections were documented. Root cause could not be determined. There were no qns issued during the production of this batch listed in the complaint. All inspections were accepted during the production of this batch. There were no issues documented about labeling. Capa not required for this event.
Patient Sequence No: 1, Text Type: N, H10
[108998297]
It was reported that a package of bd? Heparin syringe(s) were received without labels, barcodes or expirations labels. The syringes were not used and there was no report of serious injury or medical interventions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2018-00233 |
| MDR Report Key | 7526556 |
| Date Received | 2018-05-18 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-04-30 |
| Date Mfgr Received | 2018-05-02 |
| Device Manufacturer Date | 2017-09-28 |
| Date Added to Maude | 2018-05-18 |
| 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 |
| 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? HEPARIN SYRINGE |
| Generic Name | FLUSH |
| Product Code | NZW |
| Date Received | 2018-05-18 |
| Returned To Mfg | 2018-05-10 |
| Catalog Number | 306413 |
| Lot Number | 727191N |
| Device Expiration Date | 2019-03-31 |
| 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 | 2018-05-18 |