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 2020-03-14 for BD POSIFLUSH? SYRINGE 306594 manufactured by Bd Medical (bd West) Medical Surgical.
[187056259]
Investigation summary: no samples or photos were received; therefore, sample analysis could not be performed and the condition reported by the customer could not be confirmed. While a definitive root cause could not be determined, it is possible that a jam occurred at the plunger rod assembly process inducing damages to the 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: unconfirmed: bd was not able to duplicate or confirm the customer? S indicated failure as no samples or photos were returned. This is the 1st complaint for lot # 9140782 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: while a definitive root cause could not be determined, it is possible that a jam occurred at the plunger rod assembly process inducing damages to the barrel. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[187056260]
It was reported that after finishing the patient's infusion, the handle of the bd posiflush? Syringe's barrel was found damaged before using it to seal the tube. The following information was provided by the initial reporter, translated from chinese to english: after the infusion for patient was finished on 11:30, 2020-03-05, the handle of the syringe' s barrel was damaged before the using of the prefilled catheter irrigator to seal the tube, it didn't use on the child, and there was no harmful effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00247 |
| MDR Report Key | 9832601 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-14 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-05-20 |
| 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 | BD POSIFLUSH? SYRINGE |
| Generic Name | SALINE VASCULAR ACCESS FLUSH |
| Product Code | NGT |
| Date Received | 2020-03-14 |
| Catalog Number | 306594 |
| Lot Number | 9140782 |
| 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 |