MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-04 for BD INTEGRA? SYRINGE WITH DETACHABLE NEEDLE 305269 manufactured by Becton Dickinson Medical Systems.
[184161015]
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. 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. 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: no root cause can be determined as no samples were received. Rationale: capa is not necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
[184161016]
It was reported that the bd integra? Syringe with detachable needle made a "pop noise" during use and remained in the injection site. The consumer was taken to the er, where an x-ray was completed. A surgeon was visited on (b)(6) 2020, where a "fluoroscope" was done, and a "post operation clip from another incident non related to bd" was found. The following information was provided by the initial reporter: "parent reported mom gave injection to son thought needle broke off in site. Mom heard a pop noise when completed the injection and needle was still in son's site. Mom took her son to the er and they completed an xray. They then went to see a surgeon (b)(6) 2020 they completed a fluoroscope and found a post operation clip from another incident non related to bd. Mom calling bd asking of the retracting tech of the integra syringe and wants to find the needle within the syringe. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213809-2020-00160 |
| MDR Report Key | 9787278 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-04 |
| 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 | 3 |
| Brand Name | BD INTEGRA? SYRINGE WITH DETACHABLE NEEDLE |
| Generic Name | PISTON SYRINGE |
| Product Code | MEG |
| Date Received | 2020-03-04 |
| Model Number | 305269 |
| Catalog Number | 305269 |
| 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 MEDICAL SYSTEMS |
| Manufacturer Address | ROUTE 7 AND GRACE WAY CANAAN CT 06018 US 06018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-04 |