MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-19 for STATLOCK PICC PLUS SLIDING POST PEDIATRIC PAD INCLUDES SKIN PREP N/A VPPPSPCE manufactured by Bard Access Systems.
[124666562]
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of juawf135 showed two other similar product complaint(s) from this lot number. The complaints for this lot number (juawf135) have been reported from the same facility in (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[124666563]
It was reported that the initial picc line was inserted into the patient on (b)(6) 2018 as patient needs long-term antibiotics. The paediatric statlock was changed on the evening of (b)(6) 2018, and the nurse discovered on the morning of (b)(6) 2018, that the picc line slipped out 8 cm from the patient. Allegedly it had slipped out because the hub casing was dislodged from the teddy bear padding on the statlock. A new picc line was inserted for safety reasons.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2018-02950 |
| MDR Report Key | 7985586 |
| Date Received | 2018-10-19 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-09-27 |
| Date Mfgr Received | 2018-10-23 |
| Device Manufacturer Date | 2016-09-01 |
| Date Added to Maude | 2018-10-19 |
| 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 | KELSEY ERICKSON |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225937 |
| Manufacturer G1 | DAVOL SURGICAL INNOVATIONS -9616067 |
| Manufacturer Street | AVE. ROBERTO FIERRO #6408 PARQUE INDUSTRIAL AEROPUERTO |
| Manufacturer City | CD. JUAREZ, CHIH S.A. DE C.V. 32690 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32690 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STATLOCK PICC PLUS SLIDING POST PEDIATRIC PAD INCLUDES SKIN PREP |
| Generic Name | INTRAVASCULAR CATHETER SECUREMENT DEVICE |
| Product Code | KMK |
| Date Received | 2018-10-19 |
| Returned To Mfg | 2018-10-12 |
| Model Number | N/A |
| Catalog Number | VPPPSPCE |
| Lot Number | JUAWF135 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-19 |