MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for BD INTEGRA? SYRINGE WITH DETACHABLE NEEDLE 305272 manufactured by Becton Dickinson Medical Systems.
[147193002]
Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[147193003]
It was reported that while using the bd integra? Syringe with detachable needle with testosterone, the consumer noticed the medication had moved from the plunger opening and into the barrel, and after retracting the needle, the full "1. 5 ml" dosage of medication "went past the plunger" and leaked from the syringe when it was turned "upside down". The following information was provided by the initial reporter: "from phone call on 2019-03-19 17:14:42: consumer calling this case/file back. Informed using the 305272 integra syringe with testosterone. During 2 different injections occd date (b)(6) 2019 and (b)(6) 2019 both same lot number item number. Both during use retracted while depressing the viscus material with plunger pressing hard. When needle retracted the medication went past the plunger stopper and leaked out syringe. While administering medications on two separate occasions ((b)(6) 2019 and (b)(6) 2019), there was a product failure with the syringe. As the plunger was pushed to inject medication, the medication was dispersed up through the plunger and into the barrel, instead of passing through the needle in the muscle. On both administrations, it was discovered that the medication had moved through the plunger's opening and into the hollow barrel. After the syringe was withdrawn, the safety mechanism was activated retracting the needle. When the syringe was then turned upside down, medication came out. On (b)(6) 2019 bout half the dose 0. 75 ml came out and on the (b)(6) 2019, the full dose of 1. 5 ml was lost. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213809-2019-00408 |
| MDR Report Key | 8479674 |
| Date Received | 2019-04-03 |
| Date of Report | 2019-05-23 |
| Date of Event | 2019-02-27 |
| Date Mfgr Received | 2019-03-18 |
| Device Manufacturer Date | 2018-03-27 |
| Date Added to Maude | 2019-04-03 |
| 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 |
| 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 MEDICAL SYSTEMS |
| Manufacturer Street | ROUTE 7 AND GRACE WAY |
| Manufacturer City | CANAAN CT 06018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD INTEGRA? SYRINGE WITH DETACHABLE NEEDLE |
| Generic Name | PISTON SYRINGE |
| Product Code | MEG |
| Date Received | 2019-04-03 |
| Catalog Number | 305272 |
| Lot Number | 8086959 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON MEDICAL SYSTEMS |
| Manufacturer Address | ROUTE 7 AND GRACE WAY CANAAN CT 06018 US 06018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-03 |