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 2020-03-18 for UNSPECIFIED BD? NEEDLE UNKNOWN manufactured by Becton Dickinson.
[188031854]
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. 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. Investigation conclusion: bd was not able to duplicate or confirm the customer? S indicated failure as no sample, batch, or lot code was provided. This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences. Root cause description: undetermined. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[188031855]
It was reported that unspecified bd? Needle was leaking during use. This occurred on 2 occasions. The following information was provided by the initial reporter: material no. : unknown batch no. :unknown. It was reported that the customer experienced leaking form the connection between the needle and the syringe. (this complaint documents the leakage from the needle at the hub. ) per excel spreadsheet: description of issue: customer reported leaking from the connection between the needle and the syringe. Number of occurrences: 2. Did the customer insert the needle into the cartridge and encounter fill resistance? No. Proceed to step 4. For bd product only, are samples available for investigation? No. Did issue cause any injury? If yes, what type of injury? No. Medical intervention needed? If yes, who was the 3rd party and what was the assistance/treatment? N/a. Resolution: customer declined bd follow up for returning product. No further follow up is required. Cts to send replacements cartridges. Cts informed customer to call back if similar issue occur. Customer acknowledged and understood. Note: product category = needle/syringe issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2020-00440 |
| MDR Report Key | 9850887 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNSPECIFIED BD? NEEDLE |
| Generic Name | NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-18 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-18 |