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 2020-03-19 for BD 20ML SLIP TIP SYRINGE 301032 manufactured by Bd Medical (bd West) Medical Surgical.
[186323990]
Investigation summary: 10 samples were received. 5 samples are luer lock syringes and 5 are luer slip syringes. One photo was provided. It shows the samples received. Two different types. It may have happened that the associate at the syringe bulk packaging area mixed the samples from the other type. 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: root cause_ syringe bulk packaging process. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[186323991]
It was reported that bd 20ml slip tip syringe came with a mix of product types in a pack. This occurred on 8318 occasions before use. The following information was provided by the initial reporter: material no. : 301032 batch no. : 9324081. It was reported that it was discovered 20cc luer-slip syringes l-05000-004a / 23p19m0301 were mixed with 20cc luer-lock syringes within the bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00272 |
| MDR Report Key | 9856859 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-11-20 |
| 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 | BD 20ML SLIP TIP SYRINGE |
| Generic Name | PISTON SYRINGE |
| Product Code | FMF |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-17 |
| Catalog Number | 301032 |
| Lot Number | 9324081 |
| 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 | 2020-03-19 |