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? SYRINGE WITH BD LUER-LOK? TIP 309653 manufactured by Becton Dickinson And Company.
[186322833]
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: 27 samples were received. They came in sealed packaging blister. Visual inspection was performed. They all have the barrel damaged at the 35ml mark area. When the barrel got damaged the plunger rod got damaged too. 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 and the damages were not detected in the next processes. 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 lot # 9275467 for this type of defect or symptom. There was no documentation for this type of defect during the entire production run of these batch #s. Root cause description: root cause_ syringe assembly process. 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 and the damages were not detected in the next processes.
Patient Sequence No: 1, Text Type: N, H10
[186323014]
It was reported that a cracked barrel was found before use with a bd? Syringe with bd luer-lok? Tip. The following information was provided by the initial reporter, "caller wishing to report quality issue with product# 309653, lot# unknown at this time (60ml luer-lok syringe). Caller states she has quantity of 25+ syringes that have defective barrels and plungers. Per phone conversation on 3/6/2020: customer stated that the barrels are cracked and when pulling plunger back pieces are broken off. Has samples to return. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00273 |
| MDR Report Key | 9856974 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-10-02 |
| 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 | 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 | 3 |
| Brand Name | BD? SYRINGE WITH BD LUER-LOK? TIP |
| Generic Name | PISTON SYRINGE |
| Product Code | FMF |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-16 |
| Model Number | 309653 |
| Catalog Number | 309653 |
| Lot Number | 9275467 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-19 |