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 2020-03-06 for BD SYRINGE 5ML SALINE FILL 306594 manufactured by Bd Medical (bd West) Medical Surgical.
[185224406]
Initial reporter phone #: unknown. 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. Examination of the product involved may provide clarification as to the cause for the reported failure. 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. This is the 1st complaint for lot # 9107527 for this type of defect or symptom. There was no documentation for this type of defect during the entire production run of this batch.
Patient Sequence No: 1, Text Type: N, H10
[185224407]
It was reported that foreign matter was discovered prior to use with a bd syringe 5ml saline fill. The following information was provided by the initial reporter, translated from (b)(6) to english: on 16:10, (b)(6) 2020, when the ward was preparing to seal the catheter for the patient, it opened the flush (5ml), found dirt on the seal, the nurse calmed the patient, and immediately replaced the brand new flush.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00222 |
| MDR Report Key | 9800657 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-04-17 |
| Date Added to Maude | 2020-03-06 |
| 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 SYRINGE 5ML SALINE FILL |
| Generic Name | SALINE VASCULAR ACCESS FLUSH |
| Product Code | NGT |
| Date Received | 2020-03-06 |
| Catalog Number | 306594 |
| Lot Number | 9107527 |
| 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 | 2020-03-06 |