MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-12-30 for FREER SEPTUM ELEV DBL-END SH/BL 7-3/4IN RH750 manufactured by Carefusion.
[34695372]
(b)(4). If further information becomes available a follow up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[34695373]
The customer reported the sharp end of the instrument, used by a registered scrub nurse during surgery, is much sharper than normal. The customer states a baby patient was lacerated in the mid back dermis with the instrument which required compression of 5 minutes to stop the bleeding. The tethered cord procedure was completed as planned.
Patient Sequence No: 1, Text Type: D, B5
[38823881]
(b)(4): one rh750 freer septum elev dbl-end sh/bl 7-3/4in was returned as the complaint sample, etching was noted to be legible, with the lot code i15 (september 2015), the sample has possibly been in use for 3 months. Per customer complaint description the sample was reported to be sharper than normal. It was reported that the patient and the user (rn nurse) have been cut/injured by the instrument. It was not identified if the sharp end caused the cut/injury. The product/sample has a sharp end and a blunt end. It is inferred that the sharp end may have caused the cut/injury. It should be noted this complaint report captures the patient injury and the complaint report (b)(4) captures the user injury. Product was received decontaminated from customer advocacy team. Upon initial review: the sample was noted to be normal, like new, and with very few signs of usage noted on the surfaces. Signs of cleaning and dried water spots were noted. Overall the instrument was noted to be normal; no obvious non-conformances were noted. The sample is characteristic of having two working ends, one was a blunt end and the other end was the sharp end as manufactured normally; the ends are manufactured normally with a slight bend to provide leverage during use as an elevator instrument. Closer visual inspections of the working ends was performed: the blunt end was noted to be blunt/normal as manufactured, no issues were noted. The sharp end was sharp and had a bright finish as normally manufactured; no issues were noted. The sharp end was examined under 3 times magnification, two signs of usage were noted: 1 small nick on the sharp edge and a few usage scratches on the tip of the bright finished area. Functional testing of the sharp edge was performed: the sharpness testing method used in the final inspections of sharp ended products was used. Kid skin leather, stretched normally over a cylindrical empty container was used; the sharp end cut into the kid skin leather normally, no issues were noted. Furthermore, the sample? S knurled grip was noted to be normal and provided traction when holding and using under pressure. Material hardness testing was also performed; the hardness was noted to be within range (43 to 53 hrc) at 47 hrc for 420 stainless steel. It should be noted the rh750 product is marketed with a sharp end and blunt end. The specific details of the injury are not known and were not reported. The cause of the injury cannot be concluded through the evaluations and testing performed. Complaint sample was evaluated and tested to be normal; no issues were noted. Device history records for rh750 from year i15 lot code were reviewed: inspection data sheets show visual, functional and dimensional checks as passing and all work instructions were followed. No deviations or non-conformances related to the failure mode were noted. The most probable root cause is user-error, due to the fact that rh750 and similar sharp products are manufactured with a sharp end and tested for sharpness by manufacturer personnel and qa personnel. There are blunt or semi sharp alternative products available by bd/carefusion that may be better suited for this customer. Rh800 product is marketed as? Semi-sharp?.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1923569-2015-00022 |
| MDR Report Key | 5335714 |
| Report Source | USER FACILITY |
| Date Received | 2015-12-30 |
| Date of Report | 2015-12-09 |
| Date of Event | 2015-12-09 |
| Date Mfgr Received | 2016-02-10 |
| Device Manufacturer Date | 2015-09-01 |
| Date Added to Maude | 2015-12-30 |
| 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 | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION 2200 INC (ST. LOUIS) |
| Manufacturer Street | 5 SUNNEN DR |
| Manufacturer City | ST. LOUIS MO 63143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREER SEPTUM ELEV DBL-END SH/BL 7-3/4IN |
| Generic Name | ELEVATOR, ENT |
| Product Code | KAD |
| Date Received | 2015-12-30 |
| Returned To Mfg | 2016-01-04 |
| Model Number | RH750 |
| Lot Number | I15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-30 |