MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-12 for LUBRI-SIL? I.C. COMPLETE CARE? ALL-SILICONE FOLEY CATHETER TRAY 900114A manufactured by C.r. Bard, Inc. (covington) -1018233.
[183174184]
The reported event was confirmed as cause unknown. Visual evaluation of the returned sample noted one opened (without original packaging), dome drain bag with connected inlet tubing and sample port connector. Visual inspection of the sample noted a cut in the bag (likely made by the complainant for drainage) and that the outlet port had a visible blockage in the lumen. The outlet tubing was dissected to find a large piece of foreign material blocking the lumen. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use were found adequate and state the following: "[warnings] method for use do not inflate the balloon in the urethra. [the urethra may be injured. ] do not pull the catheter hard. [the bladder/urethra may be injured. ] applicable patients -patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged. ]"
Patient Sequence No: 1, Text Type: N, H10
[183174185]
It was reported that no urine would flow out of the outlet tube into the drain bag. Per additional information from the investigator via email 05feb2020, upon evaluation of the sample a foreign blockage was found in the inlet tubing of the drain bag. Per additional information from the investigator via email 19feb2020, upon further evaluation a cascading failure caused the restricted flow rate. The restricted flow rate was due to a blockage in the lumen, and the blockage was caused by a large piece of foreign material. The foreign material was the root cause of the failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01774 |
| MDR Report Key | 9824320 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-12 |
| 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 | 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUBRI-SIL? I.C. COMPLETE CARE? ALL-SILICONE FOLEY CATHETER TRAY |
| Generic Name | URINE DRAINAGE BAG (COMPLETE CARE) |
| Product Code | MJC |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-01-03 |
| Catalog Number | 900114A |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-12 |