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 2020-03-14 for SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD 306499 manufactured by Bd Medical (bd West) Medical Surgical.
[185777960]
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. 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. Based on no sample, the investigation concluded, bd was not able to verify the indicated failure. 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 # 9002664 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: undetermined. Rationale: capa not required at this time
Patient Sequence No: 1, Text Type: N, H10
[185777961]
It was reported that an unspecified number of syrs 10 ml fil saline shortlength plunger rods experienced syringe volumetric accuracy issues which were noted during use. The following information was provided by the initial reporter: material no: 306499 batch no: 9002664. Customer stated that the syringe is off by. 4 -. 6ml when aspirated with medication. He reported this happening before but said nothing came of it. He states this has been happening since november 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00249 |
| MDR Report Key | 9832849 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-14 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-14 |
| 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 | SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD |
| Generic Name | INTRAVASCULAR CATHETER |
| Product Code | NGT |
| Date Received | 2020-03-14 |
| Catalog Number | 306499 |
| Lot Number | 9002664 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-14 |