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 2020-03-16 for BD? PRE-FILLED NORMAL SALINE SYRINGE 306593 manufactured by Bd Medical (bd West) Medical Surgical.
[186331287]
Investigation summary: 2 photos were provided. They show a syringe with plunger rod. The barrel is damaged. It is likely that a jam occurred at the plunger rod assembly process inducing the damage 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: confirmed: bd was able to duplicate or confirm the customer's indicated failure mode with the photos provided. This is the 1st complaint for lot # 9108800 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: it is likely that a jam occurred at the plunger rod assembly process inducing the damage to the barrel. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[186331288]
It was reported that before use, the bd? Pre-filled normal saline syringe's handle was broken and missing, and the flange was damaged. The following information was provided by the initial reporter, translated from chinese to english: "the incident happened on 5th, and the salesman received feedback on the evening of 9th, and went to the hospital this afternoon to confirm the situation. After opening the product package, they found that the pre-filled flush handle was broken and missing, and the flange was damaged. The patient was not harmed. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00255 |
| MDR Report Key | 9836897 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-04-18 |
| Date Added to Maude | 2020-03-16 |
| 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? PRE-FILLED NORMAL SALINE SYRINGE |
| Generic Name | SALINE VASCULAR ACCESS FLUSH |
| Product Code | NGT |
| Date Received | 2020-03-16 |
| Catalog Number | 306593 |
| Lot Number | 9108800 |
| 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 | 2020-03-16 |