MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-26 for UNSPECIFIED BD SHARPS CONTAINERS UNKNOWN manufactured by Becton Dickinson.
[147611445]
Date of event: unknown. The date received by manufacturer has been used for this field. There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. (b)(4). Device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. Unable to perform dhr check due to unknown lot number. Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer? S indicated failure as no samples or photos were returned root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.
Patient Sequence No: 1, Text Type: N, H10
[147611446]
It was reported that pen needles were hard to detach from unspecified bd sharps containers. The following information was provided by the initial reporter, "material no. Unknown, batch no. Unknown. It was reported that pen needles were hard to detach from the sharps container. (b)(4) was opened to record issues with pen needle. This record was opened by request of the aeg team to capture the sharps container issue in verbatim. No additional information about the complaint is available. Verbatim:she also reported she had 2 boxes of some needle that was hard to detach the pen needle from the sharp container. No information from one box. 2nd box - lot# 8205943; expiration date-08-31-2023; item# 320109; sample discarded. Occurence-unknown. Incident date- unknown. Offered to send a voucher. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2019-00801 |
| MDR Report Key | 8556554 |
| Date Received | 2019-04-26 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-04-10 |
| Date Mfgr Received | 2019-04-10 |
| Date Added to Maude | 2019-04-26 |
| 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 | BECTON DICKINSON |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNSPECIFIED BD SHARPS CONTAINERS |
| Generic Name | SHARPS CONTAINER |
| Product Code | MMK |
| Date Received | 2019-04-26 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-26 |