MAUDE Adverse Event Report: COVIDIEN MONOJECT; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number	8881247137
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states we have had multiple safety incidents of monoject (aspirate) needles , where the metal needles separated from plastic handles.The metal needles themselves remained intact.Delay in care, extended anesthesia time, and secondary puncture for bma/biopsy after successful manipulation and removal of metal needle sheath and inner needle.No patient injury in either case.Procedures were able to be completed.
Additional Manufacturer Narrative
The device history record (dhr) review of the reported lot number provides evidence that the product was released according to all e stablished procedures and quality assurance.One used sample was received for evaluation.After a visual inspection the condition reported by the customer was confirmed; the metal needles were separated from plastic handles.The bone marrow item 633033 is not manufactured by the medtronic facility; this product is supplied by an approved supplier and is a picked-and-placed into the package at the medtronic facility as a part of the process.A possible root cause could be related to a low quantity of adhesive applied during the manufacturing process that was not culled during the inspection of the finished product causing the needle to separate from the handle.Corrective actions were performed by issuance of a supplier corrective action required (scar) issued to the supplier and subsequent corrective/preventative action (capa) issued by the supplier for the lot number related to this complaint.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MONOJECT
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• MDR Report Key: 6637656
• Report Number: 1282497-2017-05173
• Device Sequence Number: 16165935
• Product Code: GAA
• UDI-Device Identifier: 20884521020518
• UDI-Public: 20884521020518
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 8881247137
• Device Catalogue Number: 8881247137
• Device Lot Number: 170270256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 01/05/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention