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 2020-01-06 for BARD? INTRA-ABDOMINAL PRESSURE MONITORING DEVICE IAP001 manufactured by C.r. Bard, Inc. (covington) -1018233.
[178352820]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[178352821]
It was reported that the iap device was set up but not used on the patient after saline was observed to leak from where the tube went into the valve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-00116 |
| MDR Report Key | 9553585 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-01-06 |
| Date of Report | 2020-02-07 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2019-07-05 |
| Date Added to Maude | 2020-01-06 |
| 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 | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD? INTRA-ABDOMINAL PRESSURE MONITORING DEVICE |
| Generic Name | IAP MEASUREMENT KIT |
| Product Code | PHU |
| Date Received | 2020-01-06 |
| Returned To Mfg | 2019-12-31 |
| Model Number | IAP001 |
| Catalog Number | IAP001 |
| Lot Number | NGDS0622 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-06 |