MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-01-17 for SWAB ALCOHOL 100 BX 1200 SPAIN 326899 manufactured by Bd Medical - Diabetes Care.
[180723444]
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: level a investigation - complaint evaluation / complaint history check for the event(s) that occurred. Severity: s_1__; occurrence: a complaint history check was performed and this is the 2nd related complaint for foreign matter on lot # 9163840. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. If samples are received in the future the complaint will be reopened for further investigation. A review of the device history record was completed for batch #9163840. All inspections were performed per the applicable operations qc specifications. There were zero (0) notifications noted that pertained to the complaint. Investigation conclusion: as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer? S indicated failure as no samples or photos were returned. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned. Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[180723445]
It was reported that swab alcohol 100 bx 1200 (b)(6) had foreign matter in the blisters. This was discovered before use. The following information was provided by the initial reporter: the alcohol presents the same spots and haloes that appear in the blisters.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920898-2020-00014 |
| MDR Report Key | 9603709 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-13 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2019-06-12 |
| Date Added to Maude | 2020-01-17 |
| 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 | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BD MEDICAL - DIABETES CARE |
| Manufacturer Street | 1329 WEST HIGHWAY 6 |
| Manufacturer City | HOLDREGE NE 68949 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68949 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWAB ALCOHOL 100 BX 1200 SPAIN |
| Generic Name | ALCOHOL SWAB |
| Product Code | LKB |
| Date Received | 2020-01-17 |
| Catalog Number | 326899 |
| Lot Number | 9163840 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL - DIABETES CARE |
| Manufacturer Address | 1329 WEST HIGHWAY 6 HOLDREGE NE 68949 US 68949 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-17 |