MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-05 for SCRUB TRAY, 8 GAUZE 4X4'S + 4437 manufactured by Carefusion.
[10610795]
(b)(4): sample is not available, however, pictures were sent for review where it is observed the slit on the sponge top, nevertheless this is how the sponge was designed. Also according to code reported and pictures is noted that a squarter sponge was used for vaginal procedure however carefusion produced a prep kit designed for vaginal procedures code 4469a, where the sponge is a contoured shape to avoid scratches as reported in this incident. No lot number was provided, at this time is not possible to review the device history record of the affected code 4437 personnel does not contribute to failure reported, the slit found by customer is how the sponge is design. During manufacturing process no issues were observed, in addition failure reported by customer is not caused in our process. No issues with the materials during the investigation of this incident there was not any root cause identified, product is running in accordance with our procedures. In addition in accordance with our customer feedback he used a square stick sponge for a vaginal procedure even when this type of sponge is not designed for that use, actually we have another code 4469a which has a contoured stick sponge for vaginal procedures no corrective action plan is determined for this incident.
Patient Sequence No: 1, Text Type: N, H10
[20355694]
Sponge handle scratched a patient.? Information received on (b)(6) 2013 from medwatch received by carefusion number (b)(4): the customer reported as a patient safety concern. In the dry gauze preoperative skin prep trays there are yellow sponge sticks that are used for vaginal preps in the operating room. These sponge sticks are designed with a slit in the top. What the operating room staff and surgeons are concerned with is when the sponge is inserted in to the vaginal cavity that the sponge pushes back exposing the plastic stick and this has been reported to cause abrasions or lacerations. It was reported that these types of events have occurred in the past. Operating staff stated that a laceration occurred to this patient with this staff are voicing concerns with the design of the device related to patient safety. Follow up information received from the facility (b)(4) 2013: the patient was undergoing a synthetic sling placement. The patient did not require any intervention the patient actually had a scratch not a laceration. The procedure continued as planned and the patient did not require any additional follow up related to the event. The device is not available for evaluation however, pictures are available.
Patient Sequence No: 1, Text Type: D, B5
[20588883]
(b)(4), the device will not be returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2013-00006 |
| MDR Report Key | 2943363 |
| Report Source | 05 |
| Date Received | 2013-02-05 |
| Date of Report | 2013-02-15 |
| Date of Event | 2013-01-08 |
| Date Mfgr Received | 2013-01-15 |
| Date Added to Maude | 2013-02-05 |
| 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 Contact | JILL RITTORNO |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8474737294 |
| Manufacturer G1 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO85PARQUE INDUST.MEXICALI III |
| Manufacturer City | MEXICALI 21600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCRUB TRAY, 8 GAUZE 4X4'S + |
| Generic Name | SKIN AND PREP TRAY |
| Product Code | OJU |
| Date Received | 2013-02-05 |
| Model Number | 4437 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN RD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-05 |