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 2020-03-17 for BD POSIFLUSH? NORMAL SALINE SYRINGE 306547 manufactured by Bd Medical (bd West) Medical Surgical.
[186327415]
Investigation summary: one sample was received. It came in a ziploc plastic bag. It has no packaging flow wrap. It has only 9ml of a solution, the rubber stopper is past the barrel retaining ring. It has tip cap. Ftir was performed by a laboratory. It was confirmed that the solution is saline. The identification of the foreign matter was not conclusive as no similar material was found in the library. Foreign matter is unknown. Based on the sample conditions it seems it was tampered. 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: confirmed: bd was able to duplicate or confirm the customer's indicated failure mode with the sample provided. This is the 1st complaint for lot # 9351508 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. Foreign matter is unknown. Based on the sample conditions it seems it was tampered. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[186327416]
It was reported that the unopened bd posiflush? Normal saline syringe had a piece of debris found floating in it before use. The following information was provided by the initial reporter: "i just retrieved an unopen flush with a piece of debris floating in the solution. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00259 |
| MDR Report Key | 9844810 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-12-17 |
| Date Added to Maude | 2020-03-17 |
| 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 POSIFLUSH? NORMAL SALINE SYRINGE |
| Generic Name | SALINE VASCULAR ACCESS FLUSH |
| Product Code | NGT |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-03-11 |
| Model Number | 306547 |
| Catalog Number | 306547 |
| Lot Number | 9351508 |
| 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 | 2020-03-17 |