MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC (2 X 0.4 ML); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	93899
Medical Device Problem Codes	Coagulation in Device or Device Ingredient (1096); Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device analysis: visual analysis of the returned device noted "empty syringe of 1.0 ml received without cap, no needle.No defect observed to syringe." device history record summary: the release step combined with the absence of any deviation shows that no element could explain this issue: all the syringes are inspected individually after filling and no problem was detected.There was no non conformity on the different elements of the syringes (syringe, plunger, plunger rod, tip cap, finger grip).Device labeling addresses the reported event(s) as follows: "precautions ¿ failure to comply with the needle attachment instructions could result in needle disengagement and/or product leakage at the luer-lok® and needle hub connection.Health care professional instructions 9.If the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.".
Event or Problem Description
Healthcare professional reported with 1 syringe of juvéderm® ultra xc, ¿the needle busted off while injecting causing the product to come out¿ and ¿the juvéderm® had a harder consistency making it difficult to come out.¿ patient contact was made.No injury to patient, staff, or injector.The packaged needle was used.

• Brand Name: JUVEDERM ULTRA XC (2 X 0.4 ML)
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• MDR Report Key: 6648679
• Report Number: 3005113652-2017-00516
• Device Sequence Number: 1049657
• Product Code: LMH
• UDI-Device Identifier: 30888628000074
• UDI-Public: (01)30888628000074(10)H24LA60338(11)160816(17)180116
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2018
• Device Catalogue Number: 93899
• Device Lot Number: H24LA60338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR