MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP REDIKIT,W/EPINEPHRIN

Model Number 6061

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

(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.

Event Description

"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).

• Brand Name: LEEP REDIKIT,W/EPINEPHRIN
• Type of Device: LEEP REDIKIT,W/EPINEPHRIN
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 5691190
• MDR Text Key: 47342077
• Report Number: 1216677-2016-00015
• Device Sequence Number: 1
• Product Code: HEE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2016
• Device Model Number: 6061
• Device Catalogue Number: 6061
• Device Lot Number: 192335
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: 6 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/22/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention