MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-26 for HICKMAN S/L CATHETERS 0600540CE manufactured by Bard Access Systems.
[185918816]
As the lot number for the device was provided, a review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation and photos have been provided for review. The investigation of the reported event is currently underway. (expiration date: 02/2024).
Patient Sequence No: 1, Text Type: N, H10
[185918817]
It was reported that approximately five months post chronic catheter placement, during infusion of parenteral nutrition, the catheter allegedly cracked. Therefore, administration of nutrition was interrupted. Reportedly, the catheter was repaired. Patient was reported as stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-01085 |
| MDR Report Key | 9885447 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-03-29 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD SHANNON LIMITED |
| Manufacturer Street | SAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7 |
| Manufacturer City | HUMACAO 00791 |
| Manufacturer Country | RQ |
| Manufacturer Postal Code | 00791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HICKMAN S/L CATHETERS |
| Generic Name | CHRONIC CATHETER |
| Product Code | LJS |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-12 |
| Catalog Number | 0600540CE |
| Lot Number | HUDP1594 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-26 |