MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-06-01 for LEEP REDIKIT,W/EPINEPHRIN 6061 manufactured by Coopersurgical, Inc..
[47342077]
The reported event could not be verified due to the absence of the affected sample(s), it unclear whether the issue was with the syringe or needle. Three sealed kits were returned. Visual and functional verification did not reveal any concern, all expected tray contents were present and syringes worked as expected. A review of the two product complaint history noted that this reported incident was the first to be reported. The root cause as to why the needle detached from the lure is indeterminable due to the absence of the objective evidence, but it may be that the needle was improperly secured to the syringe luer. At this time it's believed that this occurrence was an isolated incident, the incident will be monitored for any possible trending.
Patient Sequence No: 1, Text Type: N, H10
[47342078]
The patient was having a leep procedure done and the needle came out of the luer lock and remained in the patients cervix. The doctor was able to retrieve the needle and no harm was reported.
Patient Sequence No: 1, Text Type: D, B5
[55340768]
(b)(4). Investigation: x-initiated manufacturer's investigation: no sample returned; review dhr. X-inspect returned samples: inspect stock product. Analysis and findings: the reported event could not be verified due to the absence of the affected sample(s), it unclear whether the issue was with the syringe or needle. Three sealed kits were returned, visual and functional verification did not reveal any concern, all expected tray contents were present and syringes worked as expected. A review of the (b)(4) product complaint history noted that this reported incident was the (b)(4) to be reported. The root cause as to why the needle detached from the lure is indeterminable due to the absence of the objective evidence, but it may be that the needle was improperly secured to the syringe lure. At this time it's believed that this occurrence was an isolated incident, the incident will be monitored for any possible trending. Corrective actions: correction and/or corrective action: corrective action is not applicable at this time as the root cause was indeterminable due to the absence of the affected product sample(s). All sealed and unopened product that was returned proved to work as expected. Corrective action level 3: train personnel; x-none. Reason: per bsr-qar-026 this complaint will be monitored for trending in that no injury was reported to end user, or patient. Was the complaint confirmed: no; review and closure: x-recommended continuous improvement program (cip). Preventative action activity: reviewed. Trend and monitor to cip.
Patient Sequence No: 1, Text Type: N, H10
[55340769]
"the patient was having a leep procedure done and the needle came out of the luer lock and remained in the patients cervix. The doctor was able to retrieve the needle and no harm was reported. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2016-00015 |
| MDR Report Key | 5691190 |
| Report Source | CONSUMER |
| Date Received | 2016-06-01 |
| Date of Report | 2016-03-28 |
| Date of Event | 2016-02-29 |
| Date Mfgr Received | 2016-02-29 |
| Device Manufacturer Date | 2016-01-22 |
| Date Added to Maude | 2016-06-01 |
| 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 | MR. NANA BANAFO |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEEP REDIKIT,W/EPINEPHRIN |
| Generic Name | LEEP REDIKIT,W/EPINEPHRIN |
| Product Code | HEE |
| Date Received | 2016-06-01 |
| Model Number | 6061 |
| Catalog Number | 6061 |
| Lot Number | 192335 |
| Device Expiration Date | 2016-10-31 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 75 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-06-01 |