MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-30 for SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS 328418 manufactured by Bd Medical - Diabetes Care.
[186206746]
Device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. Unable to perform dhr check for needle breaks off during use due to unknown lot number. Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer? S indicated failure as no samples or photos were returned. Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.
Patient Sequence No: 1, Text Type: N, H10
[186206747]
It was reported that a needle break occurred during use with a syringe 1. 0ml 31ga 8mm ufii 10bag 500cs. The following information was provided by the initial reporter, "verbatim: consumer reported that the syringe needle broke off in her stomach during injection. Stated that when she removed the syringe from the injection site she saw that there was no needle so she called the ambulance and went to the emergency room to have the needle removed. X-ray was done, needle was removed and discarded, syringe was also discarded at the emergency room. Lot # is not available, packaging was also discarded. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920898-2020-00319 |
| MDR Report Key | 9900268 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-20 |
| Date Mfgr Received | 2020-03-20 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| 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 - DIABETES CARE |
| Manufacturer Street | 1329 WEST HIGHWAY 6 |
| Manufacturer City | HOLDREGE NE 68949 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68949 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS |
| Generic Name | PISTON SYRINGE |
| Product Code | FMF |
| Date Received | 2020-03-30 |
| Model Number | 328418 |
| Catalog Number | 328418 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL - DIABETES CARE |
| Manufacturer Address | 1329 WEST HIGHWAY 6 HOLDREGE NE 68949 US 68949 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |