MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-07-20 for DELTEC? PORT-A-CATH? II EPIDURAL LOW PROFILE ACCESS SYSTEM 21-1500-22 manufactured by Smiths Medical Asd, Inc..
[80592394]
Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[80592395]
It was reported that a deltec? Port-a-cath? Ii epidural low profile access system malfunctioned; it was impossible to withdraw or inject through the device. The device in use with a patient as a part of a drug clinical trial. The position of the device was checked via x-ray. The patient required lumbar punctures for administration due to the malfunctioning device. The patient was hospitalized for removal and replacement of the access device. The patient required treatment for spasticity and pain. No permanent injury was reported, and the event was considered resolved.
Patient Sequence No: 1, Text Type: D, B5
[110477241]
One used portal and a partial percutaneous catheter was received for evaluation. Visual inspection found the catheter to have a bend at the attachment to the portal. This bed appeared consistent with the memory of placement within the patient. The strain relief connector was removed. The system was found to be occluded; in order to isolate the occlusion, the catheter was removed and the portal chamber was introduced with a water solution. No occlusion, total or partial, was observed on the port. Upon further examination of the catheter, the distal end was found to have an appearance consistent with being melted, thinned out, and compressed. This resulted in occlusion. It was unable to be determined whether the observed damage was due to handling during explant or otherwise. A review of the device history record revealed no discrepancies. While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2017-01544 |
| MDR Report Key | 6729759 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-07-20 |
| Date of Report | 2017-09-21 |
| Date of Event | 2016-06-10 |
| Date Mfgr Received | 2017-09-12 |
| Device Manufacturer Date | 2011-09-15 |
| Date Added to Maude | 2017-07-20 |
| 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 | JENNIFER MENG |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833078 |
| Manufacturer G1 | SMITHS MEDICAL OAKDALE |
| Manufacturer Street | 3350 GRANADA AVENUE NORTH SUITE 100 |
| Manufacturer City | ST. PAUL MN 55128 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55128 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELTEC? PORT-A-CATH? II EPIDURAL LOW PROFILE ACCESS SYSTEM |
| Generic Name | CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL |
| Product Code | LNY |
| Date Received | 2017-07-20 |
| Returned To Mfg | 2017-08-25 |
| Catalog Number | 21-1500-22 |
| Lot Number | 2070542 |
| Device Expiration Date | 2016-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-07-20 |