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 2020-03-19 for PAB? S5904-52 manufactured by B. Braun Medical Inc.
[186279502]
This report has been identified as b. Braun medical inc. Internal report number (b)(4). The investigation is ongoing at this time. A follow-up will be submitted when the investigation results become available.
Patient Sequence No: 1, Text Type: N, H10
[186279503]
As reported by the user facility: while making an iv solution within an empty bag, a particle was noticed in the solution. The particle appeared to be a part of the bag that had somehow become dislodged or broken off during manipulation. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021236-2020-00001 |
| MDR Report Key | 9853158 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-19 |
| 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 | MR. JONATHAN SEVERINO |
| Manufacturer Street | 861 MARCON BLVD. |
| Manufacturer City | ALLENTOWN, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 7197287 |
| Manufacturer G1 | B. BRAUN MEDICAL INC |
| Manufacturer Street | 2525 MCGAW AVENUE |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAB? |
| Generic Name | CONTAINER, IV |
| Product Code | KPE |
| Date Received | 2020-03-19 |
| Catalog Number | S5904-52 |
| Lot Number | J8J710 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC |
| Manufacturer Address | 2525 MCGAW AVENUE IRVINE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |