MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-02-27 for UNSPECIFIED BD PHASEAL? CONNECTOR UNKNOWN manufactured by Becton Dickinson.
[184433212]
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. A device history record could not be completed as no lot number was received. 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. Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[184433213]
It was reported that the unspecified bd phaseal? Connector disconnected twice during use from the injector on 2 separate dates. The device was "taped together" to keep it from falling apart again. Chemo leakage was stated to have occurred, but did not come into contact with the skin or mucosal membrane of the patient or staff, the latter of whom wore appropriate ppe. This complaint was created to capture the 1st of 2 related incidents. The following information was provided by the initial reporter: "when i went to circle prime the patient's rituxan on 9/9, the tubing became disconnected from the luer lock tubing to the injector of the phaseal. Rituxan dripped out of the bag, necessitating a spill clean up. Patient's phaseal also became disconnected twice from the injector/connector piece on 2 separate dates, so the tubing and phaseal had been changed. Last happened 9/12. Today (9/13) the phaseal has been taped together so it will not continue coming apart. This malfunction did not result in spill. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2020-00299 |
| MDR Report Key | 9765538 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-13 |
| Date of Event | 2019-09-12 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-02-27 |
| 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 PHASEAL? CONNECTOR |
| Generic Name | INTRAVASCULAR ADMINISTRATION SET |
| Product Code | ONB |
| Date Received | 2020-02-27 |
| 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 | 2020-02-27 |