MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-09 for MEDCHEM PRODUCTS UNKNOWN manufactured by Medchem Products, Inc..
[13980]
On october 11, 1994, a 78 year old female patient, had a 5g double lumen picc line placed in the radiology department. On 10/14 while turning the patient, the picc line connector piece broke off of the implanted catheter. The patient was taken to special procedures for replacement of another line due to difficulty with suitable access sites.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 21396 |
| MDR Report Key | 21396 |
| Date Received | 1995-02-09 |
| Date of Report | 1995-01-31 |
| Date of Event | 1994-10-14 |
| Date Facility Aware | 1994-10-14 |
| Report Date | 1995-01-31 |
| Date Reported to Mfgr | 1994-10-21 |
| 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 | MEDCHEM PRODUCTS |
| Generic Name | GESCO PER-Q-CATH |
| Product Code | FGH |
| Date Received | 1995-02-09 |
| Returned To Mfg | 1994-11-07 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | 030696 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 DAY |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 21433 |
| Manufacturer | MEDCHEM PRODUCTS, INC. |
| Manufacturer Address | P.O. BOX 690188 SAN ANTONIA TX 78269 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-02-09 |