MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-12-12 for B. BRAUN 8713112D manufactured by B. Braun Melsungen Ag.
[130040692]
(b)(4). The investigation into this reported event is ongoing. The device has been forwarded to b. Braun melsungen (b)(4) (manufacturer) to complete the investigation. A follow-up report will be submitted when the results of the investigation are available.
Patient Sequence No: 1, Text Type: N, H10
[130040693]
The power supply was originally reported as damaged. Once the power supply was received by (b)(4) (importer), it was visually inspected and it was discovered that the power supply exhibited signs of thermal damage.
Patient Sequence No: 1, Text Type: D, B5
[134378986]
(b)(4). The used power supply was received for evaluation, and during the initial visual examination it was discovered that the power supply exhibited signs of thermal damage. Upon further evaluation, it was determined that the pins on the primary adaptor were damaged in a way that caused them to lose connection with the board inside the power supply. The loose connection between the pins and the internal board of the power supply caused the thermal damage. Based on the condition of the power supply when it was received, the cause of the disconnection was most likely the result of the power supply being dropped several times. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number. If additional information becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610825-2018-00259 |
| MDR Report Key | 8154853 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-12-12 |
| Date of Report | 2019-01-29 |
| Date Facility Aware | 2018-11-30 |
| Report Date | 2019-01-29 |
| Date Reported to FDA | 2019-01-29 |
| Date Reported to Mfgr | 2019-01-29 |
| Date Mfgr Received | 2018-11-30 |
| Date Added to Maude | 2018-12-12 |
| 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 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4842408332 |
| Manufacturer G1 | B. BRAUN MELSUNGEN AG |
| Manufacturer Street | CARL-BRAUN-STR. 1 |
| Manufacturer City | MELSUNGEN, HESSEN 34212 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 34212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | B. BRAUN |
| Generic Name | ACCESSORIES, PUMP, INFUSION |
| Product Code | MRZ |
| Date Received | 2018-12-12 |
| Returned To Mfg | 2018-11-29 |
| Catalog Number | 8713112D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MELSUNGEN AG |
| Manufacturer Address | CARL-BRAUN-STR. 1 MELSUNGEN, HESSEN 34212 GM 34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-12 |