MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONF INTRO NDLE, BEV, 11G 6"; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	283902611
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2018 the surgeon was using (b)(4) and the surgeon twisted it and it became apparent there was a problem.The needle then broke inside the patient and my understanding is that the needle had to be left there.There were two needles involved with the same product code but they had different lot numbers ¿ hthbfk and 184350.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: CONF INTRO NDLE, BEV, 11G 6"
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7935839
• Report Number: 1526439-2018-50954
• Device Sequence Number: 856914
• Product Code: GAA
• UDI-Device Identifier: 10705034209432
• UDI-Public: (01)10705034209432
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018

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: 05/31/2020
• Device Catalogue Number: 283902611
• Device Lot Number: HTHBFK
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other