MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-15 for INFANT CATH KIT 0035630 manufactured by Productos Para El Cuidado De La Salud -9611590.
[31192406]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[31192407]
It was reported that the patient allegedly had a culture taken, and gram negative rods were observed.
Patient Sequence No: 1, Text Type: D, B5
[33853880]
The device was not returned for evaluation. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: "instructions for use: open package and remove plastic wallet. Open plastic wallet. Place infant in supine position, thighs abducted. Cleanse the area around the meatus with povidine-iodine swabs. Put on sterile gloves. Place the tip of the catheter in sterile lubricant and catheterize patient. After urine is collected, pull catheter out of cap. Tighten cap and depress spout. Label centrifuge tube. Important: use plastic wallet as sterile field. Pull catheter out of centrifuge tube to the proper length immediately after donning gloves. Note: if urine does not flow freely into the tube, the cap sterile unless package is opened or damaged. " (b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2015-00474 |
| MDR Report Key | 5224450 |
| Date Received | 2015-11-15 |
| Date of Report | 2015-11-28 |
| Date Mfgr Received | 2015-11-28 |
| Device Manufacturer Date | 2014-10-31 |
| Date Added to Maude | 2015-11-15 |
| 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 | JANNA PARKS |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 |
| Manufacturer Street | KM. 7 CARRETERA INTERNACIONAL |
| Manufacturer City | NOGALES, SONORA 85621 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 85621 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFANT CATH KIT |
| Generic Name | INFANT CATHETER |
| Product Code | FFH |
| Date Received | 2015-11-15 |
| Catalog Number | 0035630 |
| Lot Number | NGYJ1499 |
| Device Expiration Date | 2017-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 |
| Manufacturer Address | KM. 7 CARRETERA INTERNACIONAL NOGALES, SONORA 85621 MX 85621 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-15 |