MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-30 for SINGLE USE PAPER FILTER WITH INDICATOR JK095 manufactured by Aesculap Ag.
[134592531]
(b)(4). Investigation on-going. Additional information / investigation results will be provided in a supplemental report. Manufacturing site evaluation: this is a preliminary report. Only photos are available for the investigation from quality management and the products were sent to the manufacturer for an analysis. Investigation - there were visible holes in the filter. Batch history review - the device quality and manufacturing history records have been checked for the lot number and found to be according to the specifications valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause - only photos are available and it is hardly possible to determine an exact conclusion and root cause. We assume that the cause of the failure is not product related. There is the possibility that the root cause of the problem is most probably usage related. Rationale - this report will be updated when we receive a statement from the manufacturer. According to the quality standard and dhr files a material defect and production error can be excluded. Due to a similar error pattern in other complaints, there is the possibility that the holes were created mechanically by an object or by faulty handling.
Patient Sequence No: 1, Text Type: N, H10
[134592532]
It was reported that there was an issue with a couple single use paper filters. It was noticed that the filter paper in an instrument container had small holes, and the set was rejected due to concern about sterility. When reviewing the rest of the batch, it was possible to verify that there were more filters with the same defect which were not used. It was noted that the malfunction with the set was found prior to a procedure in the safety clinic and the scheduled surgery was postponed. On 21jan2019 additional clarification was received. It was confirmed that the procedure had not yet started, the patient was not under anesthesia, and there was no surgical delay. This report refers to the second filter which was confirmed upon product return (07jan2019). 9610612-2019-00023; 9610612-2019-00048 (this report).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00048 |
| MDR Report Key | 8290695 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-30 |
| Date of Report | 2019-01-31 |
| Date of Event | 2018-11-23 |
| Date Facility Aware | 2019-01-09 |
| Date Mfgr Received | 2019-01-31 |
| Device Manufacturer Date | 2018-03-05 |
| Date Added to Maude | 2019-01-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE USE PAPER FILTER WITH INDICATOR |
| Generic Name | STERILE TECHNOLOGY |
| Product Code | FRG |
| Date Received | 2019-01-30 |
| Returned To Mfg | 2019-01-07 |
| Model Number | JK095 |
| Catalog Number | JK095 |
| Lot Number | 4509477053 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-30 |