MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-19 for SYRINGE 10ML REG PR SALINE 10ML FILL 306546 manufactured by Bd Medical (bd West) Medical Surgical.
[186322053]
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(6). Investigation summary: 7 samples were received. 3 photos were provided. They came in the packaging flow wrap. They have the plunger rod-rubber stopper, the tip cap, saline solution. The barrel flange is damaged. It could have happened that a jam occurred at the plunger rod assembly process inducing damages to barrel. 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 # 9343077 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: posiflush assembly line. Plunger rod assembly. It could have happened that a jam occurred at the plunger rod assembly process inducing damages to barrel. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[186322054]
It was reported that syringe 10ml reg pr saline 10ml fill had a damaged flange. The following information was provided by the initial reporter: "it was reported that the customer stated that the flange part on the syringe is breaking when trying to push on the plunger. Verbatim: rep called to report that customer states that the flange part on the syringe is breaking when trying to push on the plunger. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00279 |
| MDR Report Key | 9857512 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-12-09 |
| 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 10ML REG PR SALINE 10ML FILL |
| Generic Name | SALINE, VASCULAR ACCESS FLUSH |
| Product Code | NGT |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-17 |
| Model Number | 306546 |
| Catalog Number | 306546 |
| Lot Number | 9343077 |
| 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 |