MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-20 for PDI POVIDONE-IODINE SWABSTICKS manufactured by Professional Disposables International, Inc..
[102891598]
Patient Sequence No: 1, Text Type: N, H10
[102891599]
The nurse practitioner was going to use povidone-iodine swabsticks for skin antiseptic for an umbilical line placement. The swab was opened by the bedside nurse to hand off in a sterile fashion to the provider placing the lines. The first stick was opened and the provider removed it from the package and it was dry and never had iodine on it. This process was repeated with 3 separate swabs that were dry without iodine. No harm to patient, but delayed the procedure while nurse located swabs with iodine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7352184 |
| MDR Report Key | 7352184 |
| Date Received | 2018-03-20 |
| Date of Report | 2018-03-08 |
| Date of Event | 2018-02-15 |
| Report Date | 2018-03-08 |
| Date Reported to FDA | 2018-03-08 |
| Date Reported to Mfgr | 2018-03-08 |
| Date Added to Maude | 2018-03-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PDI POVIDONE-IODINE SWABSTICKS |
| Generic Name | APPLICATOR, ABSORBENT TIPPED, NON-STERILE |
| Product Code | KXF |
| Date Received | 2018-03-20 |
| Lot Number | L11701386 |
| Device Expiration Date | 2019-11-30 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. |
| Manufacturer Address | 2 NICE PAK PARK ORANGEBURG NY 10962 US 10962 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-20 |