MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2016-01-18 for BD VACUTAINER? STRETCH LATEX FREE TOURNIQUET 367203 manufactured by Becton Dickinson.
[36235949]
Of note, in this emdr, bd corporate headquarters in (b)(4) has been listed. As the manufacturing site hygenic is an oem manufacturing site. Medical device expiration date: unknown. Device manufacture date: unknown. (b)(4). A review of the device history record could not be performed as a lot number for this incident was not provided. (b)(4). Of note, the quality engineer at hygenic states that propylene glycol is not in the formulation of the tourniquet.
Patient Sequence No: 1, Text Type: N, H10
[36235950]
It was reported that a bd vacutainer stretch latex free tourniquet was used to inserted a bd insyte autoguard shiedled iv catheter into a patient and the patient had an allergic reaction to it. The patient has a past medical history of an allergy to propylene glycol. The patient received an anti-allergy medication prescribed by a physician to treat the allergic reaction. It was also reported that the patient's symptoms have disappeared and that she is doing well. Of note, this complaint was initially reviewed as a non-reportable incident on (b)(6) 2015 as there was no indication that any medical intervention was provided to the patient. On 1/12/2016 the patient provided additional medical information stating that she was prescribed anti-allergy medication by a physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2016-00001 |
| MDR Report Key | 5375519 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2016-01-18 |
| Date of Report | 2016-01-18 |
| Date of Event | 2015-12-05 |
| Date Mfgr Received | 2015-12-14 |
| Date Added to Maude | 2016-01-18 |
| 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 | PATIENT |
| 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 | 8015652845 |
| 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 | 3 |
| Brand Name | BD VACUTAINER? STRETCH LATEX FREE TOURNIQUET |
| Generic Name | TOURNIQUET |
| Product Code | GAX |
| Date Received | 2016-01-18 |
| Catalog Number | 367203 |
| Lot Number | UNKNOWN |
| Operator | NURSE |
| 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. Required No Informationntervention | 2016-01-18 |