MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-21 for DESIGN OPTIONS? 560603 manufactured by B. Braun Medical Inc..
[63372889]
(b)(4). The actual device involved in the reported incident was not returned for evaluation. Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn. The investigation into this reported event is ongoing. A follow-up report will be submitted when the results of the investigation are available.
Patient Sequence No: 1, Text Type: N, H10
[63372890]
As reported by user facility: approximately 1 inch of spinal needle broke off in the patient which required the patient to return to the operating room for surgical removal of needle.
Patient Sequence No: 1, Text Type: D, B5
[65851342]
This report has been identified as b. Braun medical inc. Internal report (b)(4). The actual device involved in the reported incident was not returned for evaluation. Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn. Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number. If additional pertinent information becomes available a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523676-2016-00907 |
| MDR Report Key | 6196046 |
| Date Received | 2016-12-21 |
| Date of Report | 2016-12-05 |
| Date Mfgr Received | 2016-12-05 |
| Device Manufacturer Date | 2016-04-25 |
| Date Added to Maude | 2016-12-21 |
| 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 | MS. BRIDSEIDA MELENDEZ |
| Manufacturer Street | 901 MARCON BLVD |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 6102660500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DESIGN OPTIONS? |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2016-12-21 |
| Catalog Number | 560603 |
| Lot Number | 0061495420 |
| Device Expiration Date | 2017-11-30 |
| 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. Required No Informationntervention | 2016-12-21 |