MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-04-28 for PENCAN? 333855 manufactured by B. Braun Medical Inc..
[74005845]
(b)(4). Multiple unsuccessful attempts were made to obtain a sample and lot number. Without the actual device and/or lot number, a thorough investigation could not be performed. While we are unable to confirm the specific nature of the reported event, b. Braun performed a search of our complaint management database from 27. Apr. 2011 thru 27. Apr. 2017 for all regional anesthesia kits where there was a reported occurrence of meningitis. The search identified only one (1) prior case of a reported incident (streptococcus salivarius) in 2015 which was fully investigated and found not to be related to any defects or issues with b. Braun manufactured product. Additionally, there have been no other reports of this nature for catalog item: 333855 "p25sk spinal tray" or associated with the spinal needle (b)(4) "pencan needle g25 x 3? " utilized within the kit. We will maintain this report for further references and continue to monitor other reports for similar occurrences. If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[74005846]
As reported by the user facility: they had a female patient that received a left total hip replacement on (b)(6) 2017 in which our ref 333855 was utilized. Patient was discharged home at 1550 on (b)(6) 2017 with no noted complications. On (b)(6) 2017, the patient presented to an er with suspected bacterial spinal meningitis. Spinal block procedure was done in the pre-op area by an experienced anesthesiologist with no prior history of such complications. - unknown when patient symptoms started. - unknown how diagnosed (ie. Spinal tap or inflammation noted on ct). - unknown bacterial strain. Limited information has been provided at this time; several attempts have been made to obtain additional information.
Patient Sequence No: 1, Text Type: D, B5
[91903811]
(b)(4). Multiple unsuccessful attempts were made to obtain a sample and lot number. Without the actual device and/or lot number, a thorough investigation could not be performed. While we are unable to confirm the specific nature of the reported event, b. Braun performed a search of our complaint management database from 27. Apr. 2011 thru 27. Apr. 2017 for all regional anesthesia kits where there was a reported occurrence of meningitis. The search identified only one (1) prior case of a reported incident (streptococcus salivarius) in 2015 which was fully investigated and found not to be related to any defects or issues with b. Braun manufactured product. Additionally, there have been no other reports of this nature for catalog item: 333855 "p25sk spinal tray" or associated with the spinal needle (b)(4) "pencan needle g25 x 3? " utilized within the kit. We will maintain this report for further references and continue to monitor other reports for similar occurrences. If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523676-2017-00064 |
| MDR Report Key | 6531890 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-28 |
| Date of Report | 2017-04-27 |
| Date Mfgr Received | 2017-04-27 |
| Date Added to Maude | 2017-04-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JONATHAN SEVERINO |
| Manufacturer Street | 901 MARCON BLVD. |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENCAN? |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2017-04-28 |
| Catalog Number | 333855 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC. |
| Manufacturer Address | 901 MARCON BLVD. ALLENTOWN PA 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-04-28 |