MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-01 for SYRINGE 5ML HEPARIN 10 UNIT 306414 manufactured by Becton Dickinson And Company.
[146542571]
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: one photo was received. The photo shows two saline syringes and two heparin syringes. Two have the udi 1. 0 linear bar code and two the udi 2. 0 bar code. The udi 2. 0 bar code 2. 0 was implemented and the customer was not ready to scan it. Posiflush marketing was informed about this issue. 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 1st complaint for the lot# 827566n for the same defect or symptom. There was no documentation of issues for the complaint of batch #827566n during the production run. Root cause description: the udi 2. 0 bar code 2. 0 was implemented and the customer was not ready to scan it. Posiflush marketing was informed about this issue.
Patient Sequence No: 1, Text Type: N, H10
[146542572]
It was reported that a unspecified bd syringe had labeling error. The following was reported, "material no. Unknown, batch no. Unknown. It was reported the heparin locks no longer have barcodes on them. "good afternoon, we have been noticing our heparin and ns flushes no longer have barcodes on them? Are we ordering the wrong products or is this a permanent change? Thanks. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2019-00336 |
| MDR Report Key | 8471652 |
| Date Received | 2019-04-01 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-03-18 |
| Date Mfgr Received | 2019-03-18 |
| Device Manufacturer Date | 2018-10-03 |
| Date Added to Maude | 2019-04-01 |
| 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 | PHARMACIST |
| 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 | BECTON DICKINSON AND COMPANY |
| Manufacturer Street | 2153 12TH 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 | SYRINGE 5ML HEPARIN 10 UNIT |
| Generic Name | INTRAVASCULAR CATHETER |
| Product Code | NZW |
| Date Received | 2019-04-01 |
| Catalog Number | 306414 |
| Lot Number | 827566N |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND COMPANY |
| Manufacturer Address | 2153 12TH AVENUE COLUMBUS NE 68601 US 68601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-01 |