MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-09 for BD? ALCOHOL SWAB 326903 manufactured by Bd Medical - Diabetes Care.
[138558558]
Device expiration date: unknown. (b)(6). 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 1st related complaint for missing label content (no expiration date) on lot # 5084837. Investigation summary: customer returned photos of a bd alcohol swab from lot # 5084837 as well as a photo of a bd alcohol swab from lot # 8263720. Customer states that material other than the required one is detected (green towel) with no expiration date. The attached photos were examined and exhibited the alcohol swab packet printed in green with only the lot number printed on it while the alcohol swab packet printed in purple has the lot number, manufacturing date, and expiration date printed on it. The green swab packet (from lot # 5084837) was manufactured in 2015 while the purple swab packet (from lot # 8263720) was printed in 2018. As per manufacturing, tis change in the packaging took place in 2016. No defects were observed on either of the pictured swabs as they are both printed correctly. A review of the device history record was completed for batch #5084837. All inspections were performed per the applicable operations qc specifications. There were zero (0) notifications noted that pertained to the complaint. Note: this batch was ran prior to the packaging spec changing to have 3 lines (lot, manufacture date, expiry date). This batch only required the batch number to be printed on the packaging. Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer? S indicated failure. 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. Based on the above, no additional investigation and no capa is required at this time. Investigation conclusion: based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer? S indicated failure. 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. Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[138558559]
It was reported that 5,790 alcohol swab premium 3000 units blk experienced missing label information or illegible labelling information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920898-2019-00134 |
| MDR Report Key | 8324510 |
| Date Received | 2019-02-09 |
| Date of Report | 2019-01-25 |
| Date of Event | 2019-01-11 |
| Date Mfgr Received | 2019-01-17 |
| Device Manufacturer Date | 2015-03-25 |
| Date Added to Maude | 2019-02-09 |
| 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 | 0 |
| Brand Name | BD? ALCOHOL SWAB |
| Generic Name | ALCOHOL SWAB |
| Product Code | LKB |
| Date Received | 2019-02-09 |
| Catalog Number | 326903 |
| Lot Number | 5084837 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| 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 | 2019-02-09 |