MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-30 for BD? ORAL DISPENSING SYRINGE 305210 manufactured by Becton Dickinson Medical Systems.
[147198628]
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(6). Investigation summary: one photo received for this complaint. The actual sample associated with this complaint will be required for further analysis in order to identify the contamination found by customer. No tests performed since samples were not received. A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect investigation conclusion: we were not able to identify the foreign matter found since the one sample was not received and analyzed. Root cause description: the potential root cause for the foreign matter (fm) defect found cannot be determined based on photos provided, it is difficult to determine if the fm found is associated with our manufacturing processes based on what we know. The actual sample is required to identify the fm and evaluate other aspects of the product that could lead to a better understanding of the product defect found and the source of the problem. The syringe components (barrel, plunger, stopper) are not exposed to any solid lubricant during the manufacturing process: 1-marking, 2-assembly, and 3-packaging. Medical grade silicone is added to the inside of the barrel for proper functionality of the syringe. Silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products. It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function. The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel. Silicone has been in use in this application for over 20 years. No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant. Additionally, a complaint report from 2013 to current was performed for p/n 305210, no other similar complaints have been received as of 04/23/2019. Rationale: no corrective actions are necessary based on the defective rate identified. Batch 8263594 is considered in compliance with our product specification requirements.
Patient Sequence No: 1, Text Type: N, H10
[147198629]
It was reported that foreign residue was found in the bd? Oral dispensing syringe before use. The following information was provided by the initial reporter: the contaminated syringe was discovered prior to being used, therefore it has been determined that this did not occur at our site. Only one syringe has been observed with this defect from this batch and is not available to be returned for investigation. We performed in house testing on the syringe and there was not enough residue to perform spectral analysis but it was positive for bioburden content.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213809-2019-00486 |
| MDR Report Key | 8565372 |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-04-12 |
| Date Mfgr Received | 2019-04-12 |
| Device Manufacturer Date | 2018-09-20 |
| Date Added to Maude | 2019-04-30 |
| 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 |
| 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 | BECTON DICKINSON MEDICAL SYSTEMS |
| Manufacturer Street | ROUTE 7 AND GRACE WAY |
| Manufacturer City | CANAAN CT 06018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD? ORAL DISPENSING SYRINGE |
| Generic Name | LIQUID MEDICATION DISPENSER |
| Product Code | KYW |
| Date Received | 2019-04-30 |
| Catalog Number | 305210 |
| Lot Number | 8263594 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON MEDICAL SYSTEMS |
| Manufacturer Address | ROUTE 7 AND GRACE WAY CANAAN CT 06018 US 06018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-30 |