MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-19 for BD 20ML SLIP TIP SYRINGE 301032 manufactured by Bd Medical (bd West) Medical Surgical.
[186324515]
Investigation summary: 8 samples were received. They came in a plastic bag. Visual inspection was performed using a 10x magnifier lens. No damages to barrels were observed. Only one plunger rod has one of the ribs with a damage, the rest have no damages. 2 photos were provided. The photos show the samples that were received. After the molding process the barrel goes for printing the scale then silicone is applied; after that the plunger-rubber stopper is assembled. A jam could have occurred during the assembly process inducing the damage to the plunger rod rib. 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. This is the 1st complaint for lot # 9316374 for this type of defect or symptom.
Patient Sequence No: 1, Text Type: N, H10
[186324516]
It was reported that prior to use the syringes were discovered to be damaged with a bd 20ml slip tip syringe. This occurred with 8 syringes. The following information was provided by the initial reporter: it was reported syringes were received damaged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00275 |
| MDR Report Key | 9857076 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-11-12 |
| 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 | 9316374 |
| 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 | 2020-03-19 |