MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-01-13 for BD? ESWAB COLLECTION KIT 220245 manufactured by Becton, Dickinson & Co..
[189086081]
For oem manufacturing sites: in this mdr, (b)(4) has been listed in sections as (b)(4) is an oem manufacturing site. A device evaluation is anticipated but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[189086082]
It was reported while using a bd eswab collection kit to collect culture sample from a patient's throat the swab broke. There was no report of injury associated with the swab breaking. This was a new user and the customer was provided with additional information regarding specimen collection. Several follow-up attempts were performed with no response from the customer. No injury or further treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2020-00001 |
| MDR Report Key | 9583725 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2019-12-20 |
| Device Manufacturer Date | 2019-04-30 |
| Date Added to Maude | 2020-01-13 |
| 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 & CO. |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD? ESWAB COLLECTION KIT |
| Generic Name | MICOBIOLOGICAL SPECIMEN COLLECTION SWAB |
| Product Code | JTW |
| Date Received | 2020-01-13 |
| Catalog Number | 220245 |
| Lot Number | 190412845 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-13 |