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 SYRINGE 20ML LL BNS 301031 manufactured by Bd Medical (bd West) Medical Surgical.
[186322594]
Investigation summary: 8 samples were received. They were visually inspected with naked eye not noticing the black line; they were inspected under a 30x microscope. The fine black line was observed on each syringe. This black line was not embedded. It came from the scale printing process. It is considered acceptable. 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 # 9149677 for this type of defect or symptom. There was no documentation for this type of defect during the entire production run of this batch. Root cause description: syringe assembly printing process. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[186322595]
It was reported that 8 syringes 20ml ll bns experienced foreign matter in device cannula/needle/syringe or any fluid path component. The product defect was noted prior to use. The following information was provided by the initial reporter: material no. : 301031 batch no. : 9149677. Black hair like substance embedded in syringes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00274 |
| MDR Report Key | 9856978 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-05-29 |
| 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 | SYRINGE 20ML LL BNS |
| Generic Name | PISTON SYRINGE |
| Product Code | FMF |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-16 |
| Catalog Number | 301031 |
| Lot Number | 9149677 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 |