MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-07-18 for 2-L HUB CONNECT ASSY REPLACEMENT SET CAR-03200 manufactured by Arrow Intl., Inc..
[2836680]
It was reported the procedure was being performed on a (b)(6) male pt, (b)(6), with a medical history of renal insufficiency. The hub assembly was being prepped for use and the extension line caps were removed. During line flush with heparin they noticed the blue extension line hub was cracked. As a result, a new hub replacement set was used for the procedure. There was no delay in treatment, no pt death, and no complications were reported. See mdr # 1036844-2012-00196 for the next event involving the same pt.
Patient Sequence No: 1, Text Type: D, B5
[9983055]
(b)(4). Follow-up report will be filed if add'l info becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2012-00195 |
| MDR Report Key | 2667950 |
| Report Source | 01,07 |
| Date Received | 2012-07-18 |
| Date of Report | 2012-07-18 |
| Date of Event | 2012-05-25 |
| Date Mfgr Received | 2012-05-29 |
| Date Added to Maude | 2012-08-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 2400 BERNVILLE RD. |
| Manufacturer City | READING PA 19605 |
| Manufacturer Country | US |
| Manufacturer Postal | 19605 |
| Manufacturer Phone | 6103780131 |
| Manufacturer G1 | ARROW INTL., INC. |
| Manufacturer Street | 312 COMMERCE PL. |
| Manufacturer City | ASHEBORO NC 27203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27203 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2-L HUB CONNECT ASSY REPLACEMENT SET |
| Generic Name | CHRONIC HEMODIALYSIS CATHETER PRODUCTS |
| Product Code | NFK |
| Date Received | 2012-07-18 |
| Catalog Number | CAR-03200 |
| Lot Number | RF1083502 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTL., INC. |
| Manufacturer Address | 2400 BERNVILLE RD. READING PA 19605 US 19605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-18 |