MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-08-10 for DCP 3MM UNILATERAL PROCEDURE KIT DCP315-UNI manufactured by Quest Medical, Inc..
[1531351]
Upon review of the maude database, quest became aware of this incident being filed to the fda and crossed link to an internal complaint file. During a dcp procedure, (b)(6) md, inserted the catheter and attached the balloon catheter to the inflation device. Pressure was brought up to 8 atm and the balloon would not hold pressure. (b)(6) instructed him to disconnect and then reconnect the luer attachment and inflate the balloon again. The balloon would not hold pressure. No leaking from the inflator could be seen at either the luer attachment or anywhere on the inflation device, and no fluid was found intra-nasally from a balloon leak. Another device was opened and the case was completed without complications.
Patient Sequence No: 1, Text Type: D, B5
[8777414]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2010-00018 |
| MDR Report Key | 1798825 |
| Report Source | 05,06 |
| Date Received | 2010-08-10 |
| Date of Report | 2010-08-10 |
| Date Mfgr Received | 2010-07-14 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2010-08-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHRYN JAYNE |
| Manufacturer Street | ONE ALLENTOWN PKWY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723909800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DCP 3MM UNILATERAL PROCEDURE KIT |
| Generic Name | MANUAL OPHTHALMIC SURGICAL INSTRUMENT |
| Product Code | HNW |
| Date Received | 2010-08-10 |
| Returned To Mfg | 2009-03-02 |
| Catalog Number | DCP315-UNI |
| Lot Number | 33472 |
| Device Expiration Date | 2011-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-08-10 |