MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-19 for BARDEX? LUBRICATH? FOLEY CATHETER 0165L16 manufactured by C.r. Bard, Inc. (covington) -1018233.
[184150806]
The reported event was confirmed as manufacturing related which could be due to unclean machine or coating issue. The evaluation found black dirt embedded in the surface of the catheter. It is unknown type of foreign matter which could come in contact with the sample during the manufacturing process. The device history record was reviewed and found a possible manufacturing issue(s) that could have caused or contributed to the reported event. The instructions for use were found adequate and state the following: "1. Method for use: (1) do not inflate the balloon in the urethra. (the urethra may be injured) (2) do not pull the catheter hard. (the bladder/urethra maybe injured) 2. Applicable patients: (1) patients with delirium who might pull out catheter (when patient tugs at catheter unconsciously, the bladder and urethra may be damaged). Contraindications: 1. Method for use: (1) do not reuse. (2) do not resterilize. (3) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils). [they may damage the device and may burst balloon. ] (4) do not hold the device with forceps, etc. Avoid contact with any blades or sharp-edged instruments. [catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon. ] 2. Applicable patients: (1) do not use on patients who are or have been allergic to natural rubber latex.. "
Patient Sequence No: 1, Text Type: N, H10
[184150807]
It was reported that the catheter was discolored partly in black. The device was not used. Per additional information from the investigator via email 27feb2020, a black foreign matter was imbedded in the catheter shaft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01940 |
| MDR Report Key | 9853618 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-02-11 |
| Date Added to Maude | 2020-03-19 |
| 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 | 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 | BARDEX? LUBRICATH? FOLEY CATHETER |
| Generic Name | FOLEY CATHETER (LATEX) |
| Product Code | EZC |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-01-30 |
| Catalog Number | 0165L16 |
| Lot Number | 9AP028 |
| 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 | 2020-03-19 |