MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-05-07 for ETHIBOND EXTRA & EXCEL POLYESTER SUTURE EH7687H manufactured by Ethicon, Inc..
[3406906]
It was reported that a patient underwent a subclavian central venous catheter insertion on (b)(6) 2013 and suture was used. While suturing the skin, the needle broke. The patient was taken to the operating room to locate the needle under scopy. A surgical incision was made to remove the needle. A like device was used to stitch the catheter in place. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[10704540]
(b)(4). Conclusion: the product upon which this medwatch is based is anticipated. Once the product is received, any further information derived from the evaluation will be submitted in a supplemental 3500a form. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
Patient Sequence No: 1, Text Type: N, H10
[10855115]
(b)(4): no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2013-05133 |
| MDR Report Key | 3096319 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-05-07 |
| Date of Report | 2013-04-16 |
| Date of Event | 2013-04-12 |
| Date Facility Aware | 2013-04-12 |
| Date Mfgr Received | 2013-05-29 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2013-05-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHY RICE |
| Manufacturer Street | 4545 CREEK ROAD MAIL LOCATION 120 |
| Manufacturer City | CINCINNATI OH 45242 |
| Manufacturer Country | US |
| Manufacturer Postal | 45242 |
| Manufacturer Phone | 5133373299 |
| Manufacturer G1 | ETHICON, INC. SAN LORENZO |
| Manufacturer Street | ROAD 183, KM. 8.3 INDUSTRIAL AREA |
| Manufacturer City | HATO PR 00754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00754 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE |
| Generic Name | SUTURE, NON ABSORBABLE |
| Product Code | GAS |
| Date Received | 2013-05-07 |
| Model Number | NA |
| Catalog Number | EH7687H |
| Lot Number | EME996 |
| ID Number | NA |
| Device Expiration Date | 2017-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | ROUTE 22 WEST PO BOX 151 SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-05-07 |