MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-09 for DELTEC UNKNOWN PART #21-4003 manufactured by Pharmacia Deltec, Inc..
[20884437]
It was learned that a 49 year old female had this port-a-cath system implanted on july 10, 1994. The interventional radiology, had elected to implant the full size port-a-cath system into the left antecubital area of an obese female patient. On the third day following the implantation, the patient complained of pain during access of the system. A subsequent venogram showed that the catheter had disconnected form the portal. There was no indication of embolization of the catheter. The complete port-a-cath system was subsequently exlanted. You indicated that there was no report of injury as a result of the incident nor was there any incident related medical sequelae. The explanted port-a-cath system was returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 21392 |
| MDR Report Key | 21392 |
| Date Received | 1995-02-09 |
| Date of Report | 1995-01-31 |
| Date of Event | 1994-07-13 |
| Report Date | 1995-01-31 |
| Date Reported to Mfgr | 1994-07-15 |
| Date Added to Maude | 1995-04-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELTEC |
| Generic Name | PORT-A-CATH |
| Product Code | LKG |
| Date Received | 1995-02-09 |
| Returned To Mfg | 1994-07-22 |
| Model Number | UNKNOWN |
| Catalog Number | PART #21-4003 |
| Lot Number | 20048 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 2 DAY |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 21429 |
| Manufacturer | PHARMACIA DELTEC, INC. |
| Manufacturer Address | 126 GREY FOX ROAD ST. PAUL MN 55112 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-02-09 |