MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-09-24 for TRAY,FOLEY,16FR,5CC ULTRAMER LATEX CAT 6165LL manufactured by Covidien.
[121514812]
Submit date: 9/24/2018. The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10
[121514813]
Customer reports: the foley catheter got stuck about one inch from the urethra as it was being taken out of the patient. The nurse had attempted to deflate the balloon and did not get anything back, so the foley was pulled until it got stuck. I attempted to deflate the balloon and did not get anything back, but could feel the balloon about one inch from the tip of his penis. We then cut the foley in an effort to drain the balloon but this did not work. A 27 gauge needle was used to deflate the balloon through the patient's skin and this was successful in removing the foley.
Patient Sequence No: 1, Text Type: D, B5
[134241831]
The device history record (dhr) for lot number 705952464x indicates product and specification requirements were met with no non-conforming product identified relating to this customer report. A lot cannot be released unless it passes all quality and conformance requirements. In-process procedures are also in place to prevent nonconforming product in the manufacturing process. This ensures components and finished products meet all quality inspection standards. These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification. No product/sample was provided for evaluation. No additional information, pictures or videos were received. Therefore, a comprehensive investigation was unable to be conducted. A root cause could not be determined. This complaint will be utilized for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2018-02017 |
| MDR Report Key | 7903375 |
| Report Source | USER FACILITY |
| Date Received | 2018-09-24 |
| Date of Report | 2019-01-24 |
| Date Mfgr Received | 2018-09-05 |
| Date Added to Maude | 2018-09-24 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD IND |
| Manufacturer City | TIJUANA 22500 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAY,FOLEY,16FR,5CC ULTRAMER LATEX CAT |
| Generic Name | CATHETER, URETERAL, GASTRO-UROLOGY |
| Product Code | EYB |
| Date Received | 2018-09-24 |
| Model Number | 6165LL |
| Catalog Number | 6165LL |
| Lot Number | 705952464X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD IND TIJUANA 22500 MX 22500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-24 |