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 2017-11-06 for PREP TRAY DRY SPONGE W/GLOVE 4461A manufactured by Carefusion, Inc.
[91102056]
(b)(4) - initial/final emdr submission, should further information be received a follow up will be submitted. Sample was not received by the customer for evaluation. The device history record stated that the lot number in question was manufactured within specification in accordance to internal procedures, no issues related to this complaint were found. Quality engineers stated that the customer used the incorrect part number for the described procedure. Part number 4416a, is not intended for internal vaginal use. Therefore the most probable cause is due to user error. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[91102057]
Customer called on (b)(6) 2017 to ask if there had been any changes to the sponge sticks in the bd dry prep tray, item #4461a. Stated that patient complained of? Internal scratches? To vaginal area post vaginal procedure. Please see questions and customer responses (in red) below which i received on (b)(6): when did this happen? In the last 72 hours. This issue occurred while performing a vaginal prep on the patient? Yes. Did the clinician notice the plastic part of the sponge stick protruding when it was removed from the patient? No. Did the issue involve more than one of the sponge sticks in the tray? Uncertain. Were they able to get the lot number off the tray at issue? No. When was the patient issue identified? Post op when the patient complained of internal scratches. Were the? Scratches? Visible or internal? Internal. Was any treatment needed? No. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2017-00263 |
| MDR Report Key | 7003165 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2017-11-06 |
| Date of Report | 2017-11-03 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-10-11 |
| Date Added to Maude | 2017-11-06 |
| 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 | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREP TRAY DRY SPONGE W/GLOVE |
| Generic Name | SKIN PREP TRAY |
| Product Code | OJU |
| Date Received | 2017-11-06 |
| Catalog Number | 4461A |
| Lot Number | 0001114851 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 N. FAIRVIEW DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-06 |